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As someone who has benefitted enormously from the off-label prescribing of anti-convulsants, including gabapentin I find infuriating that this cadre of so-called researchers continue to imply that research conducted by private companies or on behalf of them is not only suspect but downright worthless and further, that off-label drug prescribing is based on an even more bastardized form such clinical information. That is not surprising since most, if not all, off-label uses are based upon clinical observations or a deeper understanding of disease mechanisms that are developed by the original use of the medicine. In fact, the critics — who have their own biases which are sustained by their own funding sources (thus, they too are financially conflicted) will be hard put to demonstrate any off-label use is any different than other domains of medical progress insofar as they are confirmed or disproved by clinical trials or rigorous observational data. People tend to forget that the first off-label use of a cancer drug (AZT) was critical in in the treatment of HIV patients or that the off-label use of thalidomide and Avastin have been associated with remarkable advances in treating cancer. The push to make off-label prescribing a criminal activity is a tragedy that will be measured in human lives…
Here’s an article from Drug Industry Daily that examines the often fine line between off-label promotion and the free and open dissemination of scientific information.
There are a number of interesting issues at play here — not the least of which is how immediately defensive and uncomfortable pharma industry antagonists become when they are asked to be as open and transparent as the industry they so brutally attack.
Here’s an inconvenient truth — When the anti-pharma gang have their feet held to the fire they get hot under the collar.
Regulatory Changes to Drug Marketing Necessary, Journal Article Says
The FDA and other regulatory agencies must step up to stem the tide of unscrupulous drug marketing practices, an Aug. 15 article in the Annals of Internal Medicine says. But former agency officials challenge the constitutionality of the recommendations and whether the government is in the best position to police the system.
Pfizer subsidiary Parke-Davis instituted a wide-ranging strategy to promote off-label drug use in the 1990s, which is indicative of fundamental ethical problems with industry marketing, the authors wrote. The study also illustrates the failings of physicians, professional organizations and the pharmaceutical industry to police such practices, they said.
However, three of the authors of the article, Michael Steinman, Mary-Margaret Chren and C. Seth Landefeld, worked as expert witnesses in a lawsuit against Parke-Davis concerning that off-label use. Also, the data used in the article was obtained by a database set up by the attorney representing the whistleblower plaintiff in that case, the report’s disclosures show.
According to the study, “Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents,’ the company used advisory boards, consultants’ meetings and accredited medical education events to get doctors to prescribe its drug Neurontin (gabapentin), an anti-seizure medication, for off-label use.
These efforts, along with recruiting doctors to influence other physicians and developing research solely to boost market share of the drug, were done without proper disclosure, they said. For example, the company’s involvement with clinical trials, medical journal research and reviews, educational grants and continuing medical education was not provided, they allege.
These findings signal a need for change, the authors said. “There is widespread agreement that commercial interests should not influence the clinical decisions that physicians make on behalf of their patients.” To address this, a complex system has developed using disclosure and self-regulation by doctors, professional organizations and industry. However, these efforts have been “largely ineffective,” as illustrated by Parke-Davis’ promotion of Gabapentin, the study said.
Incremental changes will fail because “marketing is so deeply embedded” and “the borders between research, education and promotion are more porous than is commonly recognized,” the study added.
Instead, new approaches are needed, including “rigorous regulatory oversight, strict sequestration of commercial and scientific activities and a fundamental internal reevaluation of the interactions between individual physicians, professional organizations and industry.”
Consumer advocates agree that changes are necessary. There is a growth in off-label use, many times based on little or no scientific support according to William Vaughan, senior policy analyst for Consumers Union. “Fixing this problem has to be a major priority,” he told DID. In particular, the FDA must take a stronger oversight role of off-label use.
But Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, disagreed. The FDA does not have the legal authority to restrict the dissemination of scientific information because doing so would be an unconstitutional restriction on First Amendment free speech protections, he said. In 1998, the Washington Legal Foundation successfully challenged the constitutionality of FDA restrictions on speech regarding off-label uses of FDA-approved products. This is a “closed issue,” he said.
Information also should not be discounted based on the motivations of an industry sponsor. “The public health can often coincide with private gain,” Pitts added. “Pure research is often done for a number of reasons.”
Another former FDA official, David Adams, chair of the law firm Venable’s FDA Practice Group and former director of the policy staff in the Office of the Commissioner at the agency, says that doctors should play a central role in preventing improper marketing, not the agency. “The government’s ability to regulate these interests is constrained by finite resources and constitutional protections,” he said.
“The most potent player in this arena is the physician. They have control over where they get their information on medical products, where and why they speak about medical products, who pays for their [continuing education] and what they call on regulators to do,” Adams said. “The signals are sometimes mixed.”
Pitts noted that the connection between the authors and plaintiffs in the lawsuit against Parke-Davis undermines their credibility, calling the link “extremely suspicious.” He also noted that as industry members on advisory boards have their industry connections scrutinized, industry critics should also face the same standards.
A Pfizer spokesman responded in similar fashion. “I think the financial and other connections between two of the authors of the study and a plaintiffs’ lawyer who has brought a lawsuit relating the marketing of Neurontin speaks
for itself,” said Bryant Haskins, director of corporate medial relations for Pfizer.
But Vaughan rejected this view, arguing that the facts themselves, not the background of the researchers are the issue. “It is a distraction to argue who or where the people writing the report came from,” Vaughan said.* “The proof is crystal clear: They got caught red-handed and are now using red herrings to divert people from the obvious documentation. It is an extraordinary treasure trove of documents that shows what lengths marketers will go.”
Pfizer agreed in 2004 to plead guilty to federal criminal charges, enter into a corporate integrity agreement (CIA) with the HHS Office of Inspector General and pay $430 million to settle allegations that one of its units caused doctors to submit Medicaid claims for unapproved uses of Neurontin. In 2003, sale of the drug accounted for almost $2.7 billion in profits.
Here is a link to the article: http://www.fdanews.com/did/5_161/
* The technical term for this is “pot calling kettle black.” (Note: This is my comment and does not appear in the article.)
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?