« December 2006 | Main | February 2007 »
January 28, 2007
More drug safety for children
by Michael Martell
New law cuts off standardised off-label use
On January 26, 2007 the new EU Regulation on Paediatric Medicines, adopted on December 12, 2006, has come into force. The regulation became effective immediately in each state of the European Union.
Finally, one might say. In the EU, fifty per cent or even more of medicines used in children have never been actually studied in this part of the population, but only in adults, not necessarily in the same indication (or the same disease). Doctors did not have a choice but guessing the right level of dose for their small patients or whether the drug would be suitable for children at all. The new law puts an end to the standardised Off-label use.
Because clinical trials with children take more time and tend to be more difficult, currently, pharmaceutical companies dispense with them.
In the future however, there will be some major changes for pharmaceutical companies regarding the approval for children’s drugs:
As of now, a new drug application (NDA) will have to contain clinical research data for children and adolescents, or, alternatively, needs to be indicated as unsuitable for children. The clinical research has to be based on a special paediatric investigation plan, approved by a new Committee of the EMEA with scientists of different member states of the EU. In exchange, pharmaceutical companies will receive a six-month patents extension to market the approved medicines. The patents extension will also apply for approved medicines if a paediatric investigation plan is provided.
Günter Verheugen, Vice president of the European Commission, said: "I very much welcome this landmark agreement.”
For further information click here:
http://www.medicalnewstoday.com/medicalnews.php?newsid=60672
http://www.emea.eu.int/htms/human/peg/prgfaq.htm
Posted by michael_martell at 01:21 PM
Comments (0)
| TrackBack | Permalink
January 25, 2007
When is a Drug Risk not a Drug Risk?
by Peter Pitts
When is a drug risk not a drug risk? When you don't understand it. I refer, of course, to the so-called "Brief Summary" which, as some say, is like the Holy Roman Empire -- neither brief nor a summary.
A new paper (of which I am a co-author), in the January edition of Drug Information Journal, relates new research demonstrating that as the number of listed side effects increases, patient recall decreases.
The paper, "A New Model for Communicating Risk Information in Direct-to-Consumer Print Advertisements" can be found at http://www.cmpi.org
Not rocket science. Social science
Posted by Peter Pitts at 10:02 AM
Comments (0)
| TrackBack | Permalink
January 24, 2007
A Chronic Achievement
by Peter Pitts
President Bush's State of the Union discussion of tax credits for health insurance should remind us all that the goal of health care shouldn't be, exclusively, to deal with acute medical problems -- but rather to provide patients with both the opportunity and the incentive to pursue care for chronic conditions (such as hypertension). Because, even with all of the advances in hospital care, it's still a much better deal -- both financially and personally -- to address a condition (such as hypertension) before it results in an acute, life-threatening event.
It's the same logic that propels Part D. Keep seniors healthy by providing low-cost access to the medicines they need and they (1) will be healthier, more productive citizens, and (2) will not need far more costly health care interventions (i.e., hospital procedures).
Eureka -- it works. Part D has propelled millions of seniors, for the first time, to seek out and receive appropriate treatment for their chronic conditions (such as hypertension).
And that's a success that demands greater attention. It's a success that goes a long way to improving the State of the Union.
Posted by Peter Pitts at 08:26 AM
Comments (0)
| TrackBack | Permalink
January 18, 2007
Cancer Deaths Drop For Second Straight Year Thanks to Breakthrough Drugs That Some Want To Price Control
by Peter Pitts
Here's the story according to AP:
Cancer deaths in the United States have dropped for a second straight year, confirming that a corner has been turned in the war on cancer.
After a decline of 369 deaths from 2002 to 2003, the decrease from 2003 to 2004 was 3,014 — or more than eight times greater, according to a review of U.S. death certificates by the American Cancer Society.
The drop from 2002 to 2003 was the first annual decrease in total cancer deaths since 1930. But the decline was slight, and experts were hesitant to say whether it was a cause for celebration or just a statistical fluke.
The trend seems to be real, Cancer Society officials said.
"It's not only continuing. The decrease in the second year is much larger," said Ahmedin Jemal, a researcher at the organization.
Cancer deaths dropped to 553,888 in 2004, down from 556,902 in 2003 and 557,271 in 2002, the Cancer Society found.
Experts are attributing the success to declines in smoking and to earlier detection and more effective treatment of tumors. Those have caused a fall in the death rates for breast, prostate and colorectal cancer — three of the most common cancers."
In the wake of this good news, some in Congress are seeking to price control unique drugs -- breakthrough medicines in otherwords.
Which means medicines like those that helped reduce dying due to cancer.
Which means medicines from biotech firms that create these miracles.
Posted by Peter Pitts at 09:52 AM
Comments (0)
| TrackBack | Permalink
January 17, 2007
Health news stories: What's in store for 2007?
by MaryEllen O'Donohue
Advancements in women’s health, new treatments to help manage the ever-growing diabetes epidemic, and improved food labels among other milestones of progress in disease prevention have made 2006 a truly exceptional time for improvements in our health. Media extensively focused on developments that target common conditions, providing consumers with vital health information to change their lives for the better.
With 2006 behind us, what’s in store for the year ahead? What therapeutic areas will media pay attention to? As obesity rates continue to climb, so will interest in this condition rise. In fact, there’s already been reporting of an over-the-counter obesity drug under FDA review. In addition, new research is paving the way for medicines that can stave off Alzheimer’s disease, sparking media interest in informing consumers about brighter options ahead. What’s more, media attention also will be devoted to new warnings—and possible big changes—in the food we eat, specifically processed food and restaurant meals. Finally, new drugs and technologies that target heart disease and cancer will take center stage on television and radio airways and in print headline news.
As we reflect on the latest and emerging health advances of 2006 and 2007, respectively, keep these areas of media interest in mind as you’re packaging trend stories and, generally speaking, coming up with news angles to keep the conversation of your products fresh among newsmakers.
Posted by maryellen_o'donohue at 11:35 AM
Comments (0)
| TrackBack | Permalink
January 16, 2007
JPMorgan conference reinforces consolidation
by Kelly McKenna
The recent JPMorgan Healthcare Conference held in San Francisco reinforced the continued growth and valuation of the biotech industry and big pharma's increasing efforts to capitalize on biotech’s innovative science and targeted therapeutic approaches.
Bloomberg data illustrates this growth. With the most annual acquisitions yet, 2006 showed a 32 percent increase in biotech deals, including acquisitions and product alliances, over 2005. The average premium rose 10 percent (from 23 to 33 percent). Biotech companies raise $20 billion in partnerships (over $17 billion in 2005), according to Burrill & Co. Analysts and investors agreed that deals and buyouts would continue, and bidding wars would ensue.
Pharma companies are not only focusing on biotech to build a sustainable pipeline (for example, Pfizer entered six research partnerships within the past three months), they're finally seeing the value in targeting niche patient populations and the underlying causes of disease vs. treating the symptoms alone. The risks involved with potential failure of a blockbuster drug are too great for big pharma (continuing the Pfizer example).
Pharma companies are now working to build reputations as good partners for smaller biotechs. Beyond the ability to successfully commercialize drugs, these companies need the right messaging - communicated early and often - and tangible support (e.g., a history of mutually beneficial partnerships, partner testimonials, presence at biotech forums/conferences) to be successful. Biotechs can now pick and choose their partners, so differentiation and commitment are key.
Posted by kelly_mckenna at 11:18 AM
Comments (0)
| TrackBack | Permalink
You Must Remember This ...
by Peter Pitts
Hope.
Study Links Gene to Alzheimer's Risk
By MALCOLM RITTER Tuesday, January 16, 2007 NEW YORK - A huge international study has identified a gene that apparently can raise the risk of developing the most common form of Alzheimer's disease, a discovery that may help scientists develop new treatments.
Scientists analyzed DNA from more than 6,000 people from a variety of ethnic groups and found evidence implicating certain versions of the gene, called SORL1.
It's too soon to tell how much those gene versions raise the risk of getting Alzheimer's, or what percentage of cases they account for, the researchers said. They said the effect on risk appears to be modest.
Still, if the finding is confirmed by other scientists, it would be "a very substantial step forward in our understanding of the genetics of Alzheimer's disease," said one expert not involved in the work, Jonathan Haines of Vanderbilt University.
By shedding light on the biology of the illness, the discovery could help lead scientists to find new treatments, he and other experts said.
Up to 4.5 million Americans are estimated to have Alzheimer's, which gradually destroys memory and other mental abilities. No cure has been found.
The study, released Sunday on the Web site of the journal Nature Genetics, focused on Alzheimer's that appears after age 65, the most common type.
Only one gene, called APOE, has been firmly linked to raising susceptibility to the common form. A Harvard-based group lists about 20 other genes it considers promising candidates, based on research. Some authors of the new paper said they believe the evidence for SORL1 is unusually strong.
Experts familiar with the new work said SORL1 probably is involved in Alzheimer's, but cautioned that it will be important for other scientists to confirm that. "People will jump on it pretty fast," said Rudy Tanzi of Harvard Medical School.
Gerard Schellenberg of the University of Washington said the paper's evidence is "pretty solid, so I'm optimistic that it will be replicated."
Dr. Sam Gandy, a researcher who chairs the medical and scientific advisory council of the Alzheimer's Association, which helped finance the new study, said that he doubted SORL1 or any other gene plays as big a role in causing the disease as APOE does.
The new work was reported by Dr. Peter St. George-Hyslop of the University of Toronto, Lindsay Farrer of Boston University, Dr. Richard Mayeux of the Columbia University in New York, and others in the U.S., Germany, Israel and Japan.
The new paper implicates SORL1 in Alzheimer's in two ways. First, it shows that inheriting certain variants was associated with developing the disease in seven out of nine samples of people examined. The association appeared in African-American, Caribbean Hispanic, northern European and Israeli Arab groups.
In laboratory studies, researchers also found that when they suppressed the activity of SORL1, cells made greater amounts of amyloid beta, a substance thought to play a key role in causing Alzheimer's. Researchers believe the disease-promoting variants of SORL1 act by suppressing the gene's activity.
Posted by Peter Pitts at 10:05 AM
Comments (0)
| TrackBack | Permalink
January 10, 2007
Dutch Foot in German Pharmacy Door
by Michael Martell
DocMorris manages to step into the German pharmacy market
The Dutch online and dispatch pharmacy DocMorris met some difficulties and also needed some legal finesse to get a foot into the door of the German pharmacy market. But the start has been made: Recently, the first pharmacy under the DocMorris Logo was given green lights for selling OTC medicines in St. Wendel in the West of Germany. 500 further stores are going to follow within the next three years.
The way to elude the German pharmacy legislation seems very easy. The owner of the pharmacy in St. Wendel is a certified pharmacist in Germany and is, according to German law, allowed to lead a pharmacy. Being a pharmacist is a necessary prerequisite, because it is not permitted that, for example, a foreign finance company buys in approbated specialists and opens a pharmacy store in Germany.
For the patient, the legal regulations seem uninteresting, because they certainly pay less for the OTC medicines which they can buy under the DocMorris Logo. In terms of discount, DocMorris could already disburse approximately 25 million Euro to its customers. The Federal German Pharmacist Association, in contrast, is afraid of negative effects on patient care in Germany. Is the DocMorris pharmacy in St. Wendel also the beginning of the end for the fixed price regulations regarding RX-Medications? Or do German patients even have to fear a dramatic decline in the level of health care?
If you want to read more about the DocMorris coup click here:
http://www.time.com/time/magazine/article/0,9171,901061002-1538600,00.html
http://www.heise.de/english/newsticker/news/76654
Posted by michael_martell at 10:17 AM
Comments (0)
| TrackBack | Permalink
January 04, 2007
Bitter Pills
by Peter Pitts
Excellent "special report" on counterfeit prescription medicines in the December 18, 2006 edition of BusinessWeek.
Here's the link:
http://www.businessweek.com/magazine/content/06_51/b4014064.htm
Two snippets to whet your appetite for more ...
First, as to the scope of the problem:
* Based on a study of 185 sites, Columbia University's National Center on Addiction & Substance Abuse reports that only 11% of Internet pharmacies require customers to provide a prescription. All the rest, an astounding 89%, appear to operate illegally. Conservative estimates of the number of dubious sites reach into the tens of thousands, according to Internet Crimes Group Inc., a corporate consulting firm.
And second, to those politicians and pundits who claim that counterfeiting is nothing but a Big Pharma "scare tactic," a cautionary tale:
* Craig Schmidt fell victim to questionable Internet medicine in April, 2004. The Chicago plastics salesman, then 30, was feeling the stress and back pain of long workweeks often spent on the road. Checking his e-mail one day, he noticed ads for Xanax and the painkiller Ultram. He placed $400 in orders without ever speaking to a doctor. When the pills arrived, he took one tablet of each drug and headed for an errand at the hardware store. The next thing he remembers is waking up three weeks later in the hospital. It turned out that each Xanax tablet contained 2 mg of the drug, or quadruple the usual starting dosage. The combination apparently caused him to black out and wreck his car. He had a heart attack, fell into a coma, and suffered brain damage. After an extraordinary recovery, he still takes medication to prevent severe leg spasms. "Don't do what I did," he says. "It's like playing Russian roulette."
BusinessWeek also ordered some "product" from selected websites. The Xanax the investigative team ordered had zero active ingredient, as did the Lipitor it purchased.
Counterfeiting of prescription medicines is nothing short of international prescription drug terrorism.
Posted by Peter Pitts at 08:56 AM
Comments (0)
| TrackBack | Permalink
January 02, 2007
You want fries with that?
by Peter Pitts
Meat and milk from cloned animals! Calls for absurd, unscientific labeling!
Just another day at the FDA.
According to the FDA, “the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals." In other words – GRAS.
Does this mean cloned beef in your burger? No. At tens of thousands of dollars per “founder” clone this is hardly likely (at least in the foreseeable future). So, unless you’re in the market for a $25,000 Big Mac, relax.
You want fries with that?
In the future, if and when the technology for animal cloning becomes more cost-efficient, it is possible that the meat of clone progeny could be available at retail. And milk from clones is certainly on the way a lot sooner.
By promulgating this new rule, FDA is working to advance the science of cloning -- an important advance towards creating a better, safer 21st century food supply.
"Cloning allows the possibility of identifying the healthiest and the superior sires or boars that are going to be used for breeding purposes," said Barb Glenn of the Biotechnology Industry Organization.
Dairy producers are worried about what might happen if "clone-free" products start showing up in supermarkets. "We have concerns where people are going to try to draw distinctions and differences where none exist," said Chris Galen, spokesman for the National Milk Producers Federation.
Perhaps this cause will be taken up by a new consumer advocacy organization – MOOveOn.org.
(Sorry about that.)
Posted by Peter Pitts at 08:49 AM
Comments (0)
| TrackBack | Permalink
