Pharma Threatens Massachusetts Over New Bill
26 CommentsBy Ed Silverman // August 7th, 2008 // 11:11 am
Last week, the Massachusetts state legislature passed a compromise version of the Health Care Cost and Quality act, a controversial bill that angered drugmakers and biotechs with an initial effort to greatly restrict interaction between industry and doctors, such as an outright ban on gifts. (Here it is).
The gift ban didn’t survive the compromise, but the bill would create an academic detailing program to provide unbiased information to prescribers; requires drugmakers to disclose payments to health care providers valued at $50 or more; and directs the state’s Department of Public Health to establish regulations on marketing, using the industry’s own code as a minimum standard (so, this means no branded items, such as mugs and pens; limits on meals, gifts and travel support).
The gift ban was removed from the House version after drugmakers and biotechs threatened to reduce investment in the state. Interestingly, this occurred after the BIO trade group this summer named Deval Patrick the Governor of the Year at its annual convention, instead of giving him the cold shoulder that many expected.
But removing the gift ban isn’t enough. This morning, five trade groups representing drugmakers and biotechs took out a full-page ad in The Boston Globe arguing the bill will “significantly curtail, if not end altogether, the availability of these last hope clinical trials in Massachusetts. The reason - the legislation requires companies that develop these new treatment options to disclose to their competitors the products and areas of research in which they are involved. The chilling effect that this will have on the life sciences industry in Massachusetts could not be more obvious.”
However, if you look at CHAPTER 111N in the bill, there is no requirement that companies disclose clinical trial work (please tell us if we have missed something). The bill does say companies should follow the existing industry marketing code of conduct, which allows for “compensation for the substantial professional or consulting services of a health care practitioner in connection with a genuine research project or a clinical trial.” In other words, docs can continue to get paid for doing clinical trials. So why the threat?
We are reaching out to the organizations that signed the ad and will update you with any replies or clarifications. UPDATE: Julie Corcoran, PhRMA’s deputy vp state policy, calls to say that, “from our perspective, that info speaks to proprietary information that could put us at an disadvantage…The disclosure requirements are so broad that it could put competitors at a competitive disadvantage.” She is referring to this passage:
“By July 1 of each year, every pharmaceutical or medical device manufacturing company that employs a person to sell or market a drug, medicine, chemical, device or appliance in the commonwealth shall disclose to the department of public health the value, nature, purpose and particular recipient of any fee, payment, subsidy or other economic benefit with a value of at least $50, which the company provides, directly or through its agents, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, health care practitioner or other person in the commonwealth authorized to prescribe, dispense, or purchase prescription drugs or medical devices in the commonwealth.”
As Corcoran acknowledges, the language is open to interpretation but, in her view, the requirement that the “nature and purpose” of every payment must be disclosed, could be construed as insisting clinical trial work must be laid bare for all to see. And here is a statement from PhRMA.
Condor
OT, here (forgive me, Ed!) — but. . . .
Does anyone want to play a game of “Trivial Pursuit”? Come by, and try to guess the relevant compound — from its 3D grphical rendering — c’mon, you chem heads! Do take a guess — PRIZES will be awarded (No, truly — there. will. be. prizes! — and not just a chance to buy a time-share in Boca!):
http://shearlingsplowed.blogspot.com/2008/08/trivial-pursuit-guess-compound-prize.html
Take a load off — do take a guess!
Cheers!
Justice in Michigan
As we sang long ago, “Oh, you can’t cut your mother up in Massachusetts….”
This is the place where they dump stuff in harbors and start revolutions.
Clarify the language if that is needed. But making threats in the Globe (why not the Herald?) in Red Sox Nation is not going to cut it.
Keep the faith, brothers and sisters. And, as for the letter writers, I would watch your tea.
Kathy
Companies are already required to disclose clinical trial work under FDA requirements. See http://www.clinicaltrial.gov.
Justice in Michigan
Having looked through the law, and read the letter more closely, my conclusion is that this is PhRMA/BIO political strategy at its most repulsive.
It is based on threats, lies, and hope of inducing terror. It justifies the “demonizing” about which it complains.
Whatever clarification is required will occur. But my prediction is that this particular strategy will bite them back. Big time.
Bob Freeman
Hopefully, but I doubt it will come through, the states will note not only this heavy-handed tactic, but also note the out-sourcing of R & D and manufacturing jobs, and stop giving away the farm to get these companies to set up shop in their localities. PhRMA wants it all: economic incentives, legal rights normally those of the individual, free-pricing; otherwise, “it will have a chilling effect on innovation”.
Meg
Phrma wants it their way, all the time, then wonders why the public’s opinion of the industry is down there lower than George Bush’s. These acts are sheer thuggery. Other acts add up to murder. Prison calls, Phrma.
BP Watch
The Big Pharma Mafia speaks out! These companies are like toddlers throwing tantrums, but then they add all these threats. If you don’t let me do what i want to do, I’m going to take all of my toys and go home. And, by the way, I’m going to punish all of the citizens of the state because you’re being mean to me. Sorry, but who in the h%$ll do they think they are? Above the law?
truthman30
“Sorry, but who in the h%$ll do they think they are? Above the law?”
Unfortunately yes….
B. Martin, MD
Ed, I understand the use of over-the-top imagery on blogs, but is it fair (or anywhere near accurate) to depict pharma with a gun?? They’re threatening to walk away from Massachusetts, not blow it away.
Common Sense
The ad placed by Big Pharma is ludicrous. At this point, they should know better that to continue to behave like the classless brutes that they are! They are going to turn everyone off if they keep it up. Just wait until there is a new president in DC - then they’ll really feel the heat. It doesn’t matter who gets elected. They will no longer have W to protect their butts.
CV DOC
Big pharma and the “researchers” they do business with must have something to hide! I think they do - Big pharma pays outrageous sums of money for little work and the “researchers” take home loads of cash. I’m sure that the physicians at Harvard are shaking in their boots! They and their institutions will be mortified when the numbers come out in the open. If they want to really stir the pot in MA, they should aks for records for the past 5 years. I think they and the feds may be able to recoup some tax dollars they may have missed.
Comment
You are absolutley right! Those hallowed halls of Harvard won’t be thought of as so hallowed anymore. Many of these physicians have been taking the pharma companies to the cleaners for years. If they have, they certainly don’t want it out in the open
ernest
Justice,
Massachusetts beware. Michigan’s Governor was once courted by pharma. Engler left the state. Pfeizer left the state. Unfortunately, they left behind a Drug Immunity Law that totally protects the industry from liability no matter how much harm they do or how many people they kill.
America beware. FDA preemption is next.
Dianne
Hi Ernest – The same thing that happened in Michigan can happen in any state. Pharma lobbied hard in Michigan to get their way, and it looks like they will get their way nationally via Levine FDA preemption.
Justice in Michigan
Ernest and all - As you know, the Michigan history is where I started. So, indeed, our experience here suggests that the more you accomodate, the more you get screwed in the end.
But I was careful in my initial post on this thread to refer to PhRMA and BIO - not pharma as the industry as a whole. Yes, I understand that the trade organizations purports to represent the various companies that are part of it. But I know from folks who are in those companies that K Street manipulators, like helicopter commutes to the office, does _not_ represent them, and that includes those on the marketing as well as the research side.
So here is another prediction. There will be a time when pharma will dump PhRMA, at least in its present incarnation, for a version of that organization that genuinely represents the everyday values and dedication that characterize the people who actually work in the industy.
It is PhRMA and BIO, in my view, who should beware. What is happening in Massachusetts may well be the beginning of the tea party we have needed for a long time.
Bring it on.
Ed Silverman
Hi B Martin,
I am an equal opportunity offender. I used the same image recently for a post in which a lawyer working for the state of Alabama gave drugmakers 30 days to settle Medicaid price-fixing cases or else….
http://www.pharmalot.com/2008/07/alabama-to-pharma-you-have-30-days-to-settle/
So in this case, the gun was being pointed at pharma. Sometimes, these things work both ways.
Cheers
ed
B. Martin, MD
Ok, Ed. Your license to project a little Dirty Harry-ism, I guess.
Doc
Pretty sad that state legislators are cowed by pharmas threats. Wonder where the patient fits in all this?
truthman30
“Pretty sad that state legislators are cowed by pharmas threats. Wonder where the patient fits in all this?”
Did someone just say the word “patient”? ..
“patients” were eliminated from the big pharma business model a long time ago, we’re all just “target audiences” , “statistics” and “consumers” now…
Bob Freeman
B. Martin, don’t forget the Star-Ledger was Tony Soprano’s newspaper. Perhaps the journalists pack heat just in case . . .
MedicoRex
Truthman 30 -
Doctors have “patients.” Those of us in clinical research have “subjects.” That doesn’t mean safety doesn’t come first; it simply means we don’t treat individuals as their primary care physician or specialist would. We’re blinded to their IDs for a reason.
We “eliminate” patients in order to eliminate bias. Research demands it.
It’s fun and popular to dump the invective on “Big Pharma” (whatever that is!), but the thousands and thousands of Americans engaged in pharmaaceutical research are dedicated professionals attempting to provide quality medicines and devices to the world. We also have mortgages, loans, taxes, and responsibilities just like other Americans, and few of us ever get rich.
But we don’t have “patients,” and we don’t practice medicine. Don’t blame the manufacturer when a doctor prescribes off-label or doesn’t read the package insert.
Doc
R&D people have a more science based outlook from my experience. They tend to be more objective. BUT - Sales and marketing, thats another story.
Lana Keeton
You should all read “Our Daily Meds” by Melody Petersen. Then come back to this blog…
How do the pharmaceutical companies control us??…let me count the ways…
1) $1.12 per year to continuing medical education for doctors…
2) User Fees to the FDA paying a significant amount of the FDA’s budget
3) Massive contributions to the U.S. Chamber of Commerce for:
a) electing State Supreme Court Justices sympathetic to the pharmaceutical industry.
b) capping punitive damages
c) writing amicus curae briefs to the Supreme Court to win pre-emption decisions
4) “Foundations” who secretly support the pharmaceutical industry - think Robert Wood
5) Uncounted numbers of lobbyists to the Senate and House of Representatives
6) Paid medical consultants, the page turners at doctors conferences, who sell other doctors on untested, unsafe medications and medical devices
7) pharmaceutical reps in the examining room and the operating room with doctors telling them what to prescribe and how to operate
8) Full page ads in newspapers
9) MASSIVE DIRECT TO CONSUMER TELEVISION ADS
10) Daniel Troy adding “preemption” to the FDA preamble in 2006…oh, by the way he is back selling himself to the pharmaceutical companies he was working for before he went to work at the FDA
11) Spending a $1 Billion Dollars to launch a Block Buster drug
12) Using the FDA’s 510 (k) Pre-Market Notification submission process
NOT TO CONDUCT CLINICAL TRIALS while using MILLIONS OF AMERICANS as unknowing GUINEA PIGS
whose health insurance pays for their drugs and surgeries and hospitalizations that ruin their lives
THEN BIG PHARMA INVOKES FEDERAL PREEMPTION IN A LAWSUIT SO THAT PEOPLE LIKE SYLVIA LEVINE WILL NEVER GET A PENNY WHILE THE PHARMACEUTICAL COMPANIES POCKET BILLIONS…YES BILLIONS… AND LAUGH ALL THE WAY TO THE BANK…
The Food and Drug Act of 1938 was passed in REACTION to people dying from untested elixirs sold by the snake oil salesmen.
Congress needs to ACT FOR AMERICANS, NOT REACT to the actions of of the modern day snake oil salesmen, pharmaceutical companies. Until that happens, BIG PHARMA’s GREED will continue to erode American’s civil liberties at the same time that they are picking our pockets with dangerous drugs that create higher medical costs.
That’s not everything but you get the idea…a patients advocate, founder of Truth in Medicine, Lana Keeton
Justice in Michigan
Just this bia: …”10) Daniel Troy adding “preemption” to the FDA preamble in 2006…”
While DT left FDA in 2004, he was, indeed, central in shaping the preemption preamble, as he has said himself. It was not so much “adding preemption” as making the preamble essentially all about preemption. The rest of the rules (which were “preambled”) were about labeling.
This was not an impulsive move. It was several years in the making and part of the overall preemption strategy. Several other “new” FDA rules were part of the same overall game plan - restricting companies’ ability to warn prior to FDA review, etc.
WEL
MAXIDEX WARNING
I had eye surgery and in the post-op pack was MAXIDEX(dexamethasone) drops by ALCON LABS.
Two days later I was BLIND
Use Google and enter EPOCRATES MAXIDEX to verify
WEL
MAXIDEX WARNING
I had eye surgery and in the post-op pack was MAXIDEX(dexamethasone) drops by ALCON LABS.
Two days later I was BLIND
Use Google and enter EPOCRATES MAXIDEX REACTION to verify