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FDA, MIT to collaborate on drug safety
WASHINGTON - The Food and Drug Administration and Massachusetts Institute of Technology announced Thursday an agreement to develop an automated system to detect unanticipated problems with prescription drugs and medical devices.
The system would scour federal and private health care databases in real time for unusual and emerging patterns that could indicate potential safety concerns.
The current system relies on the largely manual assessment of reports voluntarily submitted to the FDA, sometimes months or years after an event has occurred. As a result, potential problems typically are underreported, said Dr. Scott Gottlieb, the FDA’s deputy commissioner for scientific and medical affairs.
A more automated system capable of mining on the fly multiple databases, including those compiled by health insurance providers and agencies like the Veterans Administration, would be better at recognizing patterns suggestive of emerging problems, Gottlieb said.
The system would build on methods developed to identify infectious disease outbreaks, detect bioterrorism attacks and model the spread of bird flu, he said.
The FDA also plans to begin publishing reports for doctors that would alert them to potential problems with drugs and devices, Gottlieb said. That could prompt doctors to watch for similar problems and report them when found to the FDA. The reports would resemble the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report, which regularly alerts doctors to outbreaks of disease.
Lawmakers and others have stepped up their criticism of FDA safety monitoring efforts in the wake of the pain killer Vioxx being pulled from the market in 2004.
One problem is the FDA cannot require that drug makers conduct studies on the safety of prescription medications already on the market, a recent Government Accountability Office report concluded.
Gottlieb said he did not think the FDA needed additional authority to improve its safety monitoring, according to a copy of a speech he gave Thursday at MIT’s Center for Biomedical Innovation.
I see today that Merck lost a lawsuit in which the plaintiff claimed that his coronary was caused by Vioxx; the fact that the patient needed a mutiple bipass operation apparently was used against Merck, the theory being that Vioxx never should have been prescribed for him, and would not have been had adequate warning been given.
Well. Assume all that to be true. Precisely how do we know that the heart attack would not have happened had the patient not taken Vioxx? As best as I can tell, we do not. And since the doctor presumably would like to avoid a malpractice suit, his testimony ought to be taken with a small grain of salt, even if in truth he is being wholly sincere. As the burden of proof is on the plaintiff—-even if only by a preponderance of the evidence—-it strikes me that yet again jackpot justice has reared its ugly head. Clinical trials can have only so many enrolled patients, as resources are limited always and everywhere, and so if an adverse effect of a drug emerges in, say, 1 out of 100,000 patients, it might not show up in a clinical trial substantially smaller than that. Is that “negligence?” The larger fear is that the pharmaceutical sector writ large will go the way of the vaccine sector, effectively destroyed because of litigation threats. Whom are future patients going to sue because better medicines were not available?
On the heels of an article in which she ridiculed Bristol Myers Squibb for being out negotiated by Apotex, the generic drug firm which is producing a copycat of the BMS blood thinner Plavix and a previous article about drug reps in which she failed to disclose one her main sources was also promoting a movie and book about her life as a drug rep, Stephanie Saul has hit a “gag me with a spoon” low with this weeks article lionizing the chairman of Apotex, Bernard Sherman. I will spare you all the details but give you all the delicious irony…
“….The opening chapters of a draft autobiography sit amid the hundreds of pill bottles and mound of legal documents in Bernard C. ShermanÃ¢s office. It will be the story of a brainy kid born in Toronto who becomes CanadaÃ¢s richest generic drug mogul.
Though a work in progress, it has the makings of a page turner. One chapter will recount how an employee from a brand-name drug company offered to sell him secret files. Another, he says, will describe how Mr. Sherman caught a rival stealing the recipe for a blockbuster generic developed by his company, Apotex.
But what promises to be the bookÃ¢s most riveting chapter is still unfolding. It is the part where Mr. Sherman seemingly outsmarts two big drug companies, Bristol-Myers Squibb and Sanofi-Aventis, to market the first generic form of the big-selling drug Plavix five years before its patent expires. And it could conceivably end with someone in jail….”
In jail? Gee, the last time anyone was tossed in the slammer in the pharmaceutical world, I think it was in 1989 after generic drug company employees were caught bribing FDA inspectors. Does Stephanie have any basis for asserting that anyone involve could be sent to prison? Any indictments? Convictions? Guilty pleas?
And as for illegality, it was Sherman (as Saul grudgingly notes) who was linked to a company that forked overr 500K for selling drugs illegally from overseas via the mail. A man ahead of his time. What a visionary. He tells our truthseeking reporting that he just gave the firm the drugs and didn’t know where they were headed.. Really.
Anyways, we also find out in this hardhitting piece that Mr. Sherman is CanadaÃ¢s “richest men with a net worth that magazines estimate at nearly $4 billion. He and his wife, Honey, give millions to charity each year. ” Somehow Stephanie has never mentioned (she had two chances) to note that BMS gives away hundreds of millions each year.
What does Mr. Sherman do for his dough? He launches lawsuits, Lots of them, in an effort to trip up a drug company on the soundness of a patent. He spends hundreds of millions a year in legal fees to make his money. A company like BMS has been pumping Plavix profits into new drugs for cancer, schizophrenia, arthritis, etc (I know, I know, spending money on marketing medicines too, G-d forbid)
All of which has nothing to do with why Apotex and BMS were dealing. Apotex launched a lawsuit to terminate the patent life of Plavix earlier than 2011. It was trying to negotiate money to cover the fines it would have to pay if the court ruled their lawsuit as without merit. And then at the same time he was writing Congress criticizing the sort of deals he was engaging in and explaining why — though his deal with BMS seemed like more the same, it really wasn’t. Stephanie takes this letter as proof that he was dealing in good faith. Or she puts it:
“The letter Ã¢ addressed to Senator Charles E. Grassley, Republican of Iowa, and the Democrats Charles E. Schumer of New York and Herbert H. Kohl of Wisconsin Ã¢ accurately predicted that the refusal would come within weeks.”
Bernard Sherman, a prophet in our time. And in Stephane Saul he has found his acolyte and Boswell.
This week Ben Cardin, a Democrat house member in Maryland and senatorial candidate in the Nov. election held a townhall meeting with seniors on health care and Social Security. Promises not to privatize Social Security received a lot of applause but a pledge to provide full Rx coverage under Medicare by imposing price controls on drug companies received a tepid response… Oops.
Meanwhile Cardin also promised to help cure cancer by 2015, doing Andy von Eschenbach one better (he set as a goal the end of suffering and death due to cancer by the same date)… Now given that all price control regimes limit access to cancer drugs and discourage innovation, just how does Cardin propose to achieve that?
According to our colleague Sally Pipes over at the Pacific Research Institute, “Gov. Arnold Schwarzenegger is promoting his new discount drug plan as a voluntary agreement between pharmaceutical companies and the State of California. But it’s more like a raw deal.”
“The California Prescription Drug Initiative calls upon drug manufacturers to offer five million low-income Californians huge discounts on prescription medications — up to 40% on brand-name drugs and a whopping 60% on generics.”
“Presumably, drug companies should offer these discounts out of the goodness in their hearts. But if they don’t comply? Well, then they’ll be coerced by the Terminator.”
Sally, as always, has a workable, free-market solution. She writes, “There is a better way.”
And here it is …
Medco, the largest U.S. pharmacy benefits manager, whose clients include large corporations, state and local governments, health insurers and unions, has created a very troubling partnership with Consumer Reports.
Beginning today, Medco is pointing its 60-million members to Consumer Reports’ online Saving Advisor —the same program that suggests a “best buys” approach to Alzheimer’s medications.
Maybe Medco will even throw in a toaster for free.
The news story on this misadventure (which can be found at www.northjersey.com) reports that the Savings Advisor “was conducted as part of Consumer Reports Best Buy Drugs program, which is funded by the private Engleberg Foundation and the government-sponsored National Libraries of Medicine.”
What it doesn’t report is that the Engleberg Foundation is profoundly conflicted. Alfred Engleberg has earned over $100 million by successfully challenging the validity and enforceability of pharmaceutical patents and has generously shared in the resulting profits earned by generic drug makers. He is pro-compulsory licensing and against tort and medical liability reform.
The Savings Advisor generally recommends generic drugs. Surprise! Mr. Engleberg served as patent counsel to the Generic Pharmaceutical Industry Association (GPIA).
Here’s what Al Engleberg e-mailed to our buddy Jamie Love regarding implementation of the Doha Declaration,
“I thought it might be useful to put forth an idea for bridging the gap between the approach suggested by the EU and the US trade negotiators. In many respects, the idea is an obvious corollary to my paper on the importance of the use of price controls as a means of avoiding the adverse impact of full TRIPS implementation.”
And here’s something else that’s both absent from the article and not on the Consumer Reports website — this saintly not-for-profit organization receives massive funding from trial lawyers.
Yes — Medco is now married to the Mob.
(For further edification on how Consumer Reports is bastardizing evidence-based medicine, please see the drugwonks.com April 6, 2006 commentary, “Crash-Test Dummy Medicine.”)
Two good articles today about how seniors are continue to transform Medicare Part D by making better choices with better information. The first by Carol Campbell of the Newark Star-Ledger (hometown paper)
Options are available for seniors in medi-gap
Monday, August 14, 2006
BY CAROL ANN CAMPBELL
Ruth Gross plans to cancel her AARP Medicare Part D drug plan and select a different one for next year. This time, she will choose a plan without a “doughnut hole.”
You can read the rest of the article here:
Ruth is not alone. Seniors are likely to shift to higher premium plans with more coverage and begin to be even more focused on the relative cost and value of the medicines they are on. My guess is that a larger percentage of seniors will choose Medicare plans with gap coverage or joint managed care plans while the increasing transparency in prices and shift to generic will move drug and premium prices down further. Armed with information about generic and brand alternatives, price competition will become fierce. Read the article in the San Francisco Chronicle about how seniors are adjusting to and learning from their Medicare Part D experience.
A ‘hole’ lot of frustration
Gap in Medicare prescription drug plan leaves some seniors with a $2,850 surprise
Remember when the usual suspects in the heatlh care policy establishment deemed part D as doomed because seniors were too senile to make intelligent choices and that the program would wind up being MORE expensive than projected and how seniors would raise hell in October right before the election as they hit the donut hole?
Seniors are discovering that shopping and saving makes more sense than the pundits who predicted they couldn’t do either under Part D
PS. Mark McClellan just announced that the average premium for Medicare Part D plans will be $8 less than it was last year. He applauds continued plan competition and Ã¢informed choicesÃ¢ by beneficiaries
Today’s article in the Miami Herald about the plight of the young adults without insurance is all too typical of the way health care is covered.
Young adults ranked as least insuredWhen it comes to getting health insurance, young adults are left out compared with other age groups.
BY BREANNE GILPATRICK
Billie Jean Delpy, 20, never considered health insurance. A hostess at a Miami Beach restaurant, she just couldn’t afford it. Then came an earache. The pain finally sent her to the Mount Sinai emergency room, resulting in a $100 prescription and a $550 bill.
”I don’t know how I’m going to pay it,” Delpy said over the conversations of passing Lincoln Road pedestrians. With her income, rent and other expenses, it will take two to three months of saving to pay the bill, she explained.
2. Definition of a problem that only a government program can solve
With few options, they end up creating the largest uninsured age group in the county, the state and much of the nation. And the numbers aren’t going down. In Florida the percentage of uninsured young adults rose by almost one=third in the last five years, according to the Florida Health Insurance Study. For a young adult just starting out this can mean crippling medical debts that take their entire careers to pay.
3. Skew the sample to the worst possible scenario
”We’re looking at people who are making $10 an hour,” Abbate said. “So even if you’re talking about a co-pay of $10 to $20 a month, that becomes a significant amount.”
4. Ignore the facts that conflict with the conclusion you are driving to:
Such as 25 percent of the uninsured are making 250 percent of the federal poverty level, about $25000 for an individual. Another 25 percent make about 150-250 percent….
5. Don’t connect the dots
The average premium for a health plan without a deductible in Miami is $120. You can get a basic plan for as little as $35 a month and with broad coverage and a $2500 deductible for $73 a month. Which means that even if you are making $15 an hour in Florida you can afford health insurance….And you sure can pay for it if you are single person making $25K or over…
6. Ignore the fact the people have some responsibility to plan for the future.
Paying off thousands of dollars of medical bills because you didn’t want to spend $73 a month? How much do you want to bet most of these folks have cell phones or cable TV? How much of the lack of health care coverage just a failure to do what is responsible?
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.
I am quck to criticize awful reporting about medicine and medical innovation and I try to be even faster in pointing people to the best reporting on the same issues…So I apologize for not writing sooner about about Jeff Donn’s thoughtful and often moving article “Costly Drugs Force Life-Death Decisions” which hit the AP wires this past weekend.
Jeff acknowledges the value of breakthrough medicines but contrasts it with how we deal with an insurance system that fails to recognize or value them similarly or requires people to make life or death decisions about using medicines that can extend life by forcing people to pay a percentage of the cost of a new medicine (never requiring people to make the same contribution to after the fact and less effective hospital care) He writes about a woman who rather than paying nearly $20 k of the cost of Erbitux decided to refuse treatment….
“In her six decades, she had shared in a long marriage, raised three children, worked in a nursing home, painted as a hobby Ã¢ and wasn’t ready to leave it all behind. But she was also a careful spender who sometimes returned new clothes to the store, deciding she didn’t really need them.
Maybe this new drug, Erbitux, could extend her life by a small fraction, but she wouldn’t be cured. “She was just very frugal, and she said it wasn’t worth it,” her husband Larry remembers.
So she refused the treatment.”
This is a complicated area — insurance has not caught up to the realities of the new technology of medicine and the new technology itself — shifting towards targeted therapies that work well in some but not everybody — is still changing clinical practice and pricing patterns which themselves are tied to outdated ways in which drugs are developed and market expectation…At the same time, it is clear the newer therapies are allowing us to live longer and better lives which cumulatively allows us to be a more productive and humane society…
Jeff Donn manages — in a relatively short article — to capture all these issues. Link to the article is here: