Latest Drugwonks' Blog
To read the testimony of all of but one (and a half) of the witnesses who presented before the Senate HELP committee, you can't help wonder whether the object was to pay homage to the dreadful IOM report or ignore the connection between science and FDA reform. Witnesses -- with the exception of Greg Simon's Faster Cures and the head of Benefit and Risk analysis at J and J were literally tripping over themselves talking about how important it was to spend all this money on making sure each and every drug was equally safe. Only Greg and the J and J guy managed to point out that embedding bean counters and epidemiologists from the Office of Drug Safety and giving them authority over drug appovals and study designs might add to the cost and time of new drug approvals without regard to the relative benefits of medicines. And the entire discussion was disconnected from ongoing efforts by the FDA to make pre-approval a more targered path that actually focused on eliminating safety problems.
Only Greg pointed out that the real value of a cliniical ttrials registry was to help avoid potential safety flaws and develop more targeted medicines and treatment regimens on a real time basis. (I think the industry is inching towards acceptance ... as it should)
And only Greg made the point, diplomatically, that the real crisis is not a lack of safe drugs but a lack of effective CURES being developed for patients being killed and crippled by horrible illnesses. As Garret Fitzgerald cogently observed and was cogently quoted (kudos to those reporters who did their job in this regard) with respect to studies about Arcoxia, Merck's latest COX-2, the use of many drugs for broadly shared problems (pain) will have to be tailored by metabolic response, age, co-morbidity, instead of banned and panned outright.
There is an unhealthy relationship between the HELP committee and the IOM panel ... There is no speaking truth to power. Instead, it is an effort on the part of the IOM committee to pass legislation it likes. I hope the committee ignores IOM and listens to Greg Simon.
Better use of medicines in a targeted fashion require a total feedback loop and not a balance of cultures or a massive purcahse of claims databases or the FDA's equivalents of a quasi-kosher certification as the IOM proposes. It would have been nice if the IOM had some really scientists on the panel...but that would have meant having a chair who wasn't threatend byy such expertise....
Only Greg pointed out that the real value of a cliniical ttrials registry was to help avoid potential safety flaws and develop more targeted medicines and treatment regimens on a real time basis. (I think the industry is inching towards acceptance ... as it should)
And only Greg made the point, diplomatically, that the real crisis is not a lack of safe drugs but a lack of effective CURES being developed for patients being killed and crippled by horrible illnesses. As Garret Fitzgerald cogently observed and was cogently quoted (kudos to those reporters who did their job in this regard) with respect to studies about Arcoxia, Merck's latest COX-2, the use of many drugs for broadly shared problems (pain) will have to be tailored by metabolic response, age, co-morbidity, instead of banned and panned outright.
There is an unhealthy relationship between the HELP committee and the IOM panel ... There is no speaking truth to power. Instead, it is an effort on the part of the IOM committee to pass legislation it likes. I hope the committee ignores IOM and listens to Greg Simon.
Better use of medicines in a targeted fashion require a total feedback loop and not a balance of cultures or a massive purcahse of claims databases or the FDA's equivalents of a quasi-kosher certification as the IOM proposes. It would have been nice if the IOM had some really scientists on the panel...but that would have meant having a chair who wasn't threatend byy such expertise....
Merck, Lilly and Celgene have all invested heavily in technologies or companies that enable or are directly engaged in stem cell research. None of the projects are turning a profit or will likely do so for years. If Pelosi's Part D plan is implemented....slashing prices and profits of today's drugs by 40 percent with more of the same for stem cell cures in the future along with
new hurdles including comparative effectiveneess studies that take years to compelte and mandatory delays of at least a year (that's the VA anyway) in even allowing something to be used off formulary...what will happen?
Oh, and let's not forget the safety requirements that add at least two years to the time it takes to get such cures to dying patients.
Great assurances of safety in the Post-Pelosi/Waxman world means more and longer clinical trials instead of personalized medicine.
Well, the D's said they didn't want the status quo.
new hurdles including comparative effectiveneess studies that take years to compelte and mandatory delays of at least a year (that's the VA anyway) in even allowing something to be used off formulary...what will happen?
Oh, and let's not forget the safety requirements that add at least two years to the time it takes to get such cures to dying patients.
Great assurances of safety in the Post-Pelosi/Waxman world means more and longer clinical trials instead of personalized medicine.
Well, the D's said they didn't want the status quo.
Last month Rep. Henry Waxman requested an investigation of the effects of US trade policy on public health from the Government Accountability Office and called for the US to drop pressure on WHO to bury a report on trade and health critical of US policies.
Rep. Waxman said, “Administration trade agreements have numerous provisions that threaten access to affordable medicine. We have to recognise that the Bush administration’s single-minded pursuit of intellectual property protections for drug companies can have potentially devastating consequences for the public health in developing countries.â€
Last month he was just wacky. Soon he'll be wacky with a gavel.
Don't you just love oversight!
Rep. Waxman said, “Administration trade agreements have numerous provisions that threaten access to affordable medicine. We have to recognise that the Bush administration’s single-minded pursuit of intellectual property protections for drug companies can have potentially devastating consequences for the public health in developing countries.â€
Last month he was just wacky. Soon he'll be wacky with a gavel.
Don't you just love oversight!
Sometimes when you put a stake in the ground and stand up for what’s right, good things happen.
From today’s edition of the Wall Street Journal …
“In a case that adds momentum to Merck & Co.'s Vioxx defense strategy, the drug maker prevailed in the 11th trial over the painkiller after a New Orleans jury cleared the company of responsibility in a man's heart attack.â€
“Merck's win, which came after the jury deliberated just 90 minutes, gives the company a slight edge on the trial scorecard with six victories and four losses. (Another Merck victory was tossed out and will be retried in January.) It still faces some 24,000 lawsuits, however, and the pendulum could swing back in the plaintiffs' direction. Both sides are eager to notch as many early victories as possible before judges overseeing the litigation start corralling them into a settlement.â€
“Merck's strategy of fighting each lawsuit one by one, and its recent winning streak in the courtroom, have helped to restore confidence in the prospects of the Whitehouse Station, N.J., company. After being preoccupied with Merck's Vioxx liability for much of the past two years, investors lately have become much less worried about the litigation.â€
From today’s edition of the Wall Street Journal …
“In a case that adds momentum to Merck & Co.'s Vioxx defense strategy, the drug maker prevailed in the 11th trial over the painkiller after a New Orleans jury cleared the company of responsibility in a man's heart attack.â€
“Merck's win, which came after the jury deliberated just 90 minutes, gives the company a slight edge on the trial scorecard with six victories and four losses. (Another Merck victory was tossed out and will be retried in January.) It still faces some 24,000 lawsuits, however, and the pendulum could swing back in the plaintiffs' direction. Both sides are eager to notch as many early victories as possible before judges overseeing the litigation start corralling them into a settlement.â€
“Merck's strategy of fighting each lawsuit one by one, and its recent winning streak in the courtroom, have helped to restore confidence in the prospects of the Whitehouse Station, N.J., company. After being preoccupied with Merck's Vioxx liability for much of the past two years, investors lately have become much less worried about the litigation.â€
Talking about making the auto industry competitive, Senator Carl Levin and John Dingell maintained yesterday that the problem isn't the other car companies but the anti-competitive practices of other countries that allow imports to be brought in at artificially low prices that include labor costs that are lower because of subsizied health care (a factual inaccuracy but whose counting).
Let's remember that the next time Dingell and Levin and Stabenow argue for drug importation which of course a function, not of companies but of countries....
Let's remember that the next time Dingell and Levin and Stabenow argue for drug importation which of course a function, not of companies but of countries....
In am in Israel for the week visiting my son. Interesting article in the Jerusalem Post amidst the items about Hezbollah rearming, Hamas attacking and Iran building up its nuclear weaponry as it hopes the election of Democrats is the beginning of the end of American support for Israel..
Seems as though Israel's pharmaceutical industry is being hammered by counterfeits and patent theft. For those who think this is just an fiction fabricated to screw the Third World -- an idea that can get you a GENIUS AWARD.
It turns out that Israel's pharma and biotech industry has lost about $331 million a year from such practices.
The Jerusalem Post article can be found here:
Intellectual property fraud an 'epidemic'
Seems as though Israel's pharmaceutical industry is being hammered by counterfeits and patent theft. For those who think this is just an fiction fabricated to screw the Third World -- an idea that can get you a GENIUS AWARD.
It turns out that Israel's pharma and biotech industry has lost about $331 million a year from such practices.
The Jerusalem Post article can be found here:
Intellectual property fraud an 'epidemic'
The title says it all.
Click on the link below and have a look at this new op-ed from the Orange County Register:
All prescription drugs not created equal
Those in agreement stand up and shout "Me too!"
Click on the link below and have a look at this new op-ed from the Orange County Register:
All prescription drugs not created equal
Those in agreement stand up and shout "Me too!"
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
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
Medicare Drug Focus reports that new HIV drugs Atripla and Prezista have been quickly adopted by Part D plans. Some have flat co-pays while others have special tier payments until out of pocket costs exceed the catastrophic level.
Two points: Neither drug are on the VA formulary. In fact they are not even available on an off-formulary fashion for at least a year..
Second, if the Dems have their way, patients would have almost no commercial information about such new medicines. Zero. Zip. Is it ethical to impose a gag order on companies that want to tell patients about a medicine that is a critical part of a HIV drug cocktail make sense? What about a new drug for Parkinson's or Alzheimer's or cancer? How about an orphan drug that prevents a kid from dying from a rare metabolic disorder? Should it be against the law for a company to tell parents about such medicine? Put another way, who would trust an HMO to let people know about a new and expensive medication without prompting?
Two points: Neither drug are on the VA formulary. In fact they are not even available on an off-formulary fashion for at least a year..
Second, if the Dems have their way, patients would have almost no commercial information about such new medicines. Zero. Zip. Is it ethical to impose a gag order on companies that want to tell patients about a medicine that is a critical part of a HIV drug cocktail make sense? What about a new drug for Parkinson's or Alzheimer's or cancer? How about an orphan drug that prevents a kid from dying from a rare metabolic disorder? Should it be against the law for a company to tell parents about such medicine? Put another way, who would trust an HMO to let people know about a new and expensive medication without prompting?
Revoke non-interference and replace it with "government pricing?"
PAUSE ... NOT!
Says who? See below.
"We are seeing large-scale negotiations with drug manufacturers, but they are conducted by private drug plans, not by the government. … A robust marketplace with a lot of competitors has driven down prices. It's the magic of the market. To assume that the government, in our genius, could improve on this belies the reality of a complex task."
− HHS Secretary Michael Leavitt, The New York Times, 11/13/06
"Both The Non-Partisan Congressional Budget Office And Medicare Actuaries Have Said They Doubt The Government Could Negotiate Lower Costs Than The Private Sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs."
"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06)
"Government Price Negotiation "Could Leave People Without Drugs That Manufacturers Decide Aren't Sufficiently Profitable Under The Plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."
"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06
"Part D Seems To Be Working. Average monthly premiums this year were $24, one-third lower than projected, according to Centers for Medicare and Medicaid Services. More than 75% of seniors say they are satisfied with the benefit, five recent independent surveys found."
"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06
"It Is Not Obvious That Allowing The Government To Negotiate With Pharmaceutical Companies Will Lead To Lower Prices Than Those Achieved By Private Drug Plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters."
Stanford Business School's Alain Enthoven and Kyna Fong, Op-Ed, "Pelosi On Drugs," The Wall Street Journal, 11/13/06
"By Acting As One Large Buyer, The Government Will Cause Price Discounts To Become More Expensive For Pharmaceutical Companies. In other words, the minimum price that the pharmaceutical company is able to accept increases. All else equal, this will lead to higher, not lower, prices. When private drug plans are negotiating individually with pharmaceutical companies, those companies have the power to 'price discriminate,' meaning they can charge lower prices to some drug plans and higher prices to others. This ability allows for large discounts."
Stanford Business School's Alain Enthoven and Kyna Fong, Op-Ed, "Pelosi On Drugs," The Wall Street Journal, 11/13/06
"Neither Economic Theory Nor Historical Experience Suggests Government Price Negotiation Will Achieve Lower Drug Prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."
Stanford Business School'svAlain Enthoven and Kyna Fong, Op-Ed, "Pelosi On Drugs," The Wall Street Journal, 11/13/06
PAUSE ... NOT!
Says who? See below.
"We are seeing large-scale negotiations with drug manufacturers, but they are conducted by private drug plans, not by the government. … A robust marketplace with a lot of competitors has driven down prices. It's the magic of the market. To assume that the government, in our genius, could improve on this belies the reality of a complex task."
− HHS Secretary Michael Leavitt, The New York Times, 11/13/06
"Both The Non-Partisan Congressional Budget Office And Medicare Actuaries Have Said They Doubt The Government Could Negotiate Lower Costs Than The Private Sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs."
"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06)
"Government Price Negotiation "Could Leave People Without Drugs That Manufacturers Decide Aren't Sufficiently Profitable Under The Plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."
"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06
"Part D Seems To Be Working. Average monthly premiums this year were $24, one-third lower than projected, according to Centers for Medicare and Medicaid Services. More than 75% of seniors say they are satisfied with the benefit, five recent independent surveys found."
"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06
"It Is Not Obvious That Allowing The Government To Negotiate With Pharmaceutical Companies Will Lead To Lower Prices Than Those Achieved By Private Drug Plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters."
Stanford Business School's Alain Enthoven and Kyna Fong, Op-Ed, "Pelosi On Drugs," The Wall Street Journal, 11/13/06
"By Acting As One Large Buyer, The Government Will Cause Price Discounts To Become More Expensive For Pharmaceutical Companies. In other words, the minimum price that the pharmaceutical company is able to accept increases. All else equal, this will lead to higher, not lower, prices. When private drug plans are negotiating individually with pharmaceutical companies, those companies have the power to 'price discriminate,' meaning they can charge lower prices to some drug plans and higher prices to others. This ability allows for large discounts."
Stanford Business School's Alain Enthoven and Kyna Fong, Op-Ed, "Pelosi On Drugs," The Wall Street Journal, 11/13/06
"Neither Economic Theory Nor Historical Experience Suggests Government Price Negotiation Will Achieve Lower Drug Prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."
Stanford Business School'svAlain Enthoven and Kyna Fong, Op-Ed, "Pelosi On Drugs," The Wall Street Journal, 11/13/06
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
