|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 03-01-2007
Drug Partnership Introduces Cheap Antimalaria Pill
International Herald Tribune, 3-1-07
Kudos to the pharmaceutical company SanofiAventis and the charity group Doctors Without Borders for joining hands to launch a new combination antimalarial treatment in poor nations where the disease is endemic. It is also refreshing to see that DWB has done something to work constructively with "Big Pharma" companies as opposed to simply bashing them.
The medicine, called ASAQ, is a pill combining artemisinin, invented in China using sweet wormwood and hailed as a miracle malaria drug, with amodiaquine, an older drug that still works in many malarial areas.
A treatment will cost less than $1 for adults and less than 50 cents for children. Adults with malaria will take only two pills a day for three days, and the pill will come in three smaller onceaday sizes for infants, toddlers and youngsters.
In Africa, malaria kills 3,000 babies and children each day, but combination drugs like this are not available for children under 11 pounds, and they require taking a larger number of pills each day, as many as 24 for some adult versions.
"This is a good thing," said Dr. Arata Kochi, chief of the World Health Organization's global malaria program, who has publicly demanded that drug companies stop making pills that contain artemisinin alone because they will lead to resistant strains of malaria. "They're responding to the kind of drug profile we've been promoting."
Doctors like to treat diseases with multidrug cocktails because it cuts down the chance that resistance to any one drug will develop.
Adm. R. Timothy Ziemer, coordinator of President Bush's $1.2 billion Malaria Initiative, said the program would be willing to buy the new pill, assuming it meets international safety standards and is requested by countries the initiative supports.
Sanofi-Aventis, the world's fourthlargest drug company, based in Paris, will sell the pill at cost to international health agencies like the W.H.O., Unicef and the Global Fund for AIDS, Tuberculosis and Malaria.
The rollout of the drug is the result of a two-year partnership between Sanofi and the Drugs for Neglected Diseases Initiative, a campaign started by the medical charity Doctors Without Borders to find new drugs for tropical diseases...
Sanofi-Aventis also seems to be taking a very innovative approach to the pricing and patenting of its new medicine:
...[the company] has decided not to seek any patents so the pills can be freely copied by generic companies like those in India. The drugs themselves are too old to patent, but the onepill formulation could have been.
Sanofi will also produce a branded version, called Coarsucam, for the private market, to be sold at three or four times the public price. It will be sold only in Africa, Indonesia and the Philippines, the company said, not in the United States or Europe.
In another innovation, Sanofi will meet with pharmacists' organizations in poor countries and give them incentives to sell Coarsucam at two different pricesat less than $1 to very poor customers and $3 to $4 to wealthier ones.
The company won't make much (if any) profit on the drug, but it should help to build markets for pharmaceuticals in poorer countries where there are at least some patients that can afford to pay higher prices for critical medicines.
If companies can find ways to build market share and profits in these countries, industry will have much better incentives to invest in drugs for these markets, thus improving global health.
Report Blasts FDA's System to Track Drugs
Wall Street Journal, 3-3-07
A consulting group has weighed in with a new report criticizing the FDA's current adverse even reporting systema report that the FDA heavily disputes. What no one seems to argue, however, is that the FDA needs more funding to improve its current system.
The FDA's drug-tracking system, called the Adverse Event Reporting System, consists of a database and other software and hardware that amass and help sift reports of potential side effects that have been filed by drug makers, doctors and others. The data are the FDA's main way to detect drug-related hazards, and can lead to changes in label warnings or even withdrawals of drugs from the market.
But, the report says, FDA safety experts waste timean average of 45 minutes per daydealing with the inefficiencies and snags caused by the current software. The Adverse Event Reporting System is overwhelmed by the growing volume of adverse-event reports, which exceeds 400,000 a year, the report says.
The FDA track record on drug safety has faced harsh scrutiny in the wake of major problems, including the 2004 withdrawal of the painkiller Vioxx after it was linked to cardiovascular problems. Such incidents underscore the importance of monitoring drugs after they go on the market, where some end up being prescribed to millions of patients. In clinical trials conducted before FDA approval, drugs typically are tested on thousands of people at mostnot enough to turn up every potential danger.
The FDA has sought to upgrade the technology used in its safety-tracking program for years. But efforts that date back at least to 2003 haven't produced the planned successor to the Adverse Event Reporting System, dubbed AERS II. Instead, the Breckenridge report says a new system isn't likely to be up and running until 2009 at the earliest, and that the FDA has wasted an estimated $25 million on its efforts. The report argues that the FDA could have had a new Adverse Event Reporting System working in 2005 if it had simply relied on off- the-shelf software.
A document prepared by FDA officials in response to the report, which is marked as a draft, said it is "riddled with editorial conclusions based on misleading or incorrect facts." Douglas Throckmorton, deputy director of the agency's drug center, said the current Adverse Event Reporting System "is a system that is working" despite "exploding" amounts of data. "Is it the best it can be? Of course not," he said. The FDA wants to develop a replacement "as quickly as anyone else does, but we want it to be done right."
Echoing other recent outside examinations of the FDA, the Breckenridge analysts say the "root cause" of the problems can be found in the culture of the agency's drug regulators. More specifically, the report largely blames a "lack of effective leadership and management" by the center's Office of Information Technology, which it says mishandled the initiative through bureaucratic infighting, flawed planning and duplicative work performed by outside contractors.
Embattled FDA chief fights back
Houston Chronicle, 3-4-07
The Chronicle interviews FDA Commissioner Andrew Von Eschenbach, who asks "How many cheerleaders have you seen on the streets for the FDA?" The Commissioner's point is well taken. Hindsight is 20/20, and it is always possible to second guess its regulatory decisions. As a result, the agency is always open to criticism, particularly on Capitol Hill.
With 12,000 employees and an annual budget of more than $2 billion, the FDA has enormous reach. It is responsible for approving the gamut of medical devices and drugs, from cancer treatment for humans to motion-sickness medicine for dogs. The agency, created just more than a century ago, is also charged with monitoring the safety of the bulk of the nation's food supply, recently issuing warnings about tainted spinach and peanut butter.
In an interview with the Houston Chronicle, von Eschenbach expressed frustration with the mounting criticism of his agency.
"It is a team few people fully appreciate. It is a team where people make decisions and immediately their motives are questioned," he said. "It is very hard for people to work under those conditions. How many cheerleaders have you seen on the streets for the FDA?" …
He has sought to motivate agency scientists by stressing their vital role. The commissioner related the story of how one of his daughter's friends who had cancer had called him. The woman, who was having a birthday party for her 6-year-old daughter, told von Eschenbach she was running out of options and asked whether there was anything else to treat her cancer because she wanted to survive to be there for her daughter's next birthday.
"You are what will determine whether there will be anything else," von Eschenbach told his FDA employees. "There can be nothing else without the FDA. We regulate everything."
Off label use common in kids
This article underscores how little we know about how drugs approved to treat adults are being used for children. Some experts estimate that about 15% of all prescription drugs are used off-label (i.e., for uses not officially approved by the FDA). For some uses, like oncology and pediatrics, the rate is much, much higher.
As we noted in our earlier discussion of drug-eluting stents, better postmarket surveillance would help us use all medicines—generic and branded—with greater precision and effectiveness.
Nearly 80 percent of hospitalized children receive drugs that have been approved only for adults, according to the largest-ever study to look at off-label use in the pediatric setting.
The researchers who conducted the study are urging both the pharmaceutical industry and the Food and Drug Administration to play a role in addressing the findings, which appear in the March issue of the Archives of Pediatrics and Adolescent Medicine.
"We need to do more," lead author Samir Shah, a pediatrician specializing in infectious diseases at The Children's Hospital of Philadelphia, told United Press International.
"When almost 80 percent of patients receive a drug off-label, that's a situation that is unacceptable," added Shah, who also serves as senior scholar at the center for clinical epidemiology and biostatistics at the University of Pennsylvania.
The trend of off-label use in the pediatric setting may even be higher than the study findings suggest, because the researchers only considered age and did not include other off-label uses, such as for unapproved diseases or other indications.
"Our study really underestimated the magnitude of off-label drug use because all we looked at was age, not indication," Shah said.
The main concern is that since these drugs have not been formally studied in children, the risks and benefits in this patient population are unknown.
"This is a pretty big issue," Shah said. "These are sick children we're talking about, and we probably need to look into those issues more closely."
Although the findings don't reveal whether the off-label use is having a negative impact on patients, they do show that there is a significant financial toll.
The expenditure of the off-label use amounted to $270 million, or 40 percent of the total dollars spent on children's medication in the study.
AARP: Prescription Drug Prices Up; Trade Group Calls AARP Report Inaccurate and Misleading
Every quarter the AARP releases a study of prescription drug inflation—and every quarter it's misleading. The problem is that the AARP quotes list prices for drugs, which is not the true average price of the medicine. Pharmacy benefit managers, HMOs, hospitals, employers, seniors with Medicare drug coverage, etc. all receive their drugs at heavily discounted rates.
Why is the AARP using this sleight of hand to distort drug prices? Because it is in favor of government price negotiations and drug importation—two policies that would effectively lead to drug price controls in the U.S. market. This would dampen incentives for pharmaceutical innovation and hurt seniors—but the AARP apparently cares more about cheaper drugs today than better medicines tomorrow.
Prescription drug prices soared nearly twice as high as inflation last year, the AARP announced today.
But a drug industry trade group calls the AARP report "inaccurate and misleading."
The AARP reports a 6.2% rise in the manufacturer list price for the brand-name prescription drugs studied. That's almost double America's general inflation rate of 3.2% in 2006.
That translates to a rise of nearly $272 in 2006 in drugs costs for the typical older American, who takes four prescription drugs, says the AARP, assuming that only brand-name drugs are used and that the full price increase is passed on to the consumer.
However, the Pharmaceutical Research and Manufacturers of America (PhRMA) says government data put prescription drug inflation at 1.5% for 2006, with slowing growth in prescription drug prices.
The AARP report covers 193 brand-name prescription drugs and 75 generic prescription drugs commonly used by adults aged 50 and older, according to AARP Pharmacy Service Data.
The report only tracks manufacturer list price. That's the price drugmakers set for wholesalers and other direct drug purchasers, not counting rebates. It's not necessarily what you pay at the pharmacy.
Kennedy urges tough tests for generic biologic drugs
The Boston Globe, 3-7-07
In the midst of a heated Congressional debate over rules that should govern a new process for approving so-called "biogenerics" (copycat versions of biotech drugs whose patents have expired), U.S. Senator Ted Kennedy (D-MA) has called for an approval process with strong safeguards, including new clinical testing.
We have a responsibility to expand the horizons of medical science in every responsible way possible so people can live longer and fuller lives," Kennedy said yesterday in a statement. "Our goal in legislation should be to enable companies to invest in new medical breakthroughs while doing all we can to cut costs for patients and protect safety."
Following Europe's example would give generic manufacturers guidance about the type of analyses and clinical trials needed to gain FDA regulatory approval, according to a Kennedy staffer.
Kennedy's willingness to require generic-biologic manufacturers to conduct clinical trials is a stance endorsed by local biotech leaders, including Genzyme Corp. and Biogen Idec Inc. Both companies sell brand-name biologic drugs and could face competition from generic versions.
"The public safety is at stake. The public confidence is at stake. You can't force the issue. You have to do it carefully," said Henri Termeer, Genzyme chief executive.
Termeer expects US regulators ultimately will follow the European example, even if it slows approval times for generic biologics. "It's very carefully considered wording where every protein—because every protein is different—is considered by itself."
Tim Hunt, a Biogen Idec spokesman, is among those who argue that waiving clinical trial requirements for manufacturers of generic versions of biologics is "lowering the bar on drug safety. To achieve safety, you're probably going to need to run clinical trials," Hunt said.
Schumer and other congressional backers of the bill object to the biotechnology industry's criticism.
"Safety is not an issue here. It's a bogus issue brought by those who wish to prevent change," Schumer said last month when the bill was introduced in the House and Senate. "We can be very smart about how we do this. We want the science to take the lead."
The science is apparently on Senator Kennedy's side. Experts agree that at least some of the most complex new biotech medicines could not be copied without clinical testing to ensure that generic versions are as safe as the originals. This may not always be the case—manufacturing science may advance to the point where clinical testing is not needed—but this is a prudent policy until then.