Policy and Medicine

Grassley and Dingell: Wanted a New Sherriff for the FDA

We need a new Sherriff is the call of several key members of congress including (Senator Grassley, Republican from Iowa and Congressman John Dingell, Democrat from Michigan).

Between the Tomatoes or Jalapeño’s you make the call and the Chinese Heparin crisis,  plus a myriad of problems with post launch pharmaceuticals and devices.  These members of congress are calling for the FDA to change the way they fundamentally do business.

In a Wall Street Journal Article titled: Grassley, Dingell Lead Calls
For Overhauling FDA

According to the report:

The lawmakers say an FDA restructuring should build a much taller wall between the agency and the industry it regulates. The FDA would gain authority to recall drugs, which it can't do today, and to impose significant fines on drug companies for safety violations. The lawmakers also want the FDA to inspect generic-drug makers before approving a new product. Perhaps most importantly, they want the next president to appoint a tough FDA commissioner completely independent from the industry.

FDA officials "are too cozy with the companies they regulate," Mr. Grassley said, adding that new leadership must "fix the culture."

Billy Tauzin, president PhRMA, said he has warned members about what may lie ahead. "It's an accumulation of things some companies did over the years. Now it's death by a thousand cuts," he said in an interview. "We gotta stop the bleeding."

To lay the groundwork for their FDA overhaul, Messrs. Dingell and Grassley and their allies have ordered about 20 investigations of drugs and issues involving the FDA. Agency officials have spent hundreds of hours testifying before Congress.

In January 2009, one thing we can count on is a new administration and a new FDA Commissioner who will more than likely have no ties whatsoever to industry, so to all those academic physicians who are doing double duty as advisors to the presidential campaigns in the hope of landing the top FDA Job, if you have done research or spoken on behalf of industry there will be no need to apply for the commissioner’s job.

Wall Street Journal: Grassley, Dingell Lead Calls For Overhauling FDA

Drug Development – The need for a little serendipity

Why does drug development require so much serendipity?  Why do drugs take so long to develop?  Why is there are there so many troubles with the development pipelines of so many companies.  To help answer some of these questions David Shaywitz, MD and Nassim Nicholas Taleb wrote in an editorial in the Financial Times that Drug research needs serendipity.

Drug development takes a lot of hard work (“Science is hard spreadsheets are easy”) along with a certain amount of serendipity.

Serendipity is the effect by which one accidentally discovers something fortunate, especially while looking for something else entirely.

.The writers rightly focus that too much reliance on spreadsheets vs. better understanding of the mechanism of disease, has lead to many potential compounds being shelved.

Pharmaceutical companies are also waking up to the fact that perhaps they shouldn’t be doing everything and focus on their core competencies which may lay in sales, marketing, re-imbursement and regulatory compliance.

“If pharma companies want to stay in the game, their leaders will need to resist the false comfort of revenue predictions and valuation spreadsheets, and instead resolve to look uncertainty in the face, acknowledge its presence and embrace the opportunity it represents.

As policy makers consider new laws to restrict marketing of branded pharmaceuticals there needs to be some consideration of the complexity of the market place, and the complexity and art of developing new compounds.

I think we would all agree that this industry could use a little serendipity.

Drug research needs serendipity

Grassley: GAO Looks at Off Label Marketing

This weekend the Associated Press (AP) wrote a story FDA Faulted over unapproved uses of medications  about a draft of  a yet to be released report from the Government Accounting Offices (this is the investigation watchdog group for congress) on the FDA oversight of off label advertising.  The draft report is not complementary of the FDA citing that it takes an average of seven months for a company get cited for off label promotion and another four months for the companies to fix the problem and come in to compliance with the FDA.

So what is the extent of the “problem” From 2003-2007, the FDA issued 42 notices of possible violations, (this amounts to little over 8 violations per year) given the thousands of drugs and possible scenarios, this is a very small number.  When they are cited this usually prompted the drug maker to drop its promotional claims.

Senator Grassley is quoted in the article:

The situation has raised concerns for Sen. Charles Grassley of Iowa, who fears that federal programs such as Medicare and Medicaid are paying billions for medications used for questionable purposes while bulking up the bottom line for pharmaceutical companies. Indeed, a 2006 study suggested that more than 20 percent of prescriptions written in the United States are for off-label use. 

Un cited sources “2006 study” are not the same as real research, many of the off label uses of medications are following peer reviewed studies that show patients benefit from their use.  I would not want to tell the patient dying of cancer that “because the FDA has not approved this medication that would save your life, we can’t give it to you.”  We need to take a hard look at which is more important “saving lives and better quality of life for our patients or saving taxpayers dollars, and those are not necessarily the same goal.

The cases included a drug approved for breast cancer and rectal cancer that also was being promoted for treatment of gastric, cervical, uterine, ovarian, renal, bladder, thyroid and liver cancers.  Cancer is one of those questionable area’s for off label promotion, in that most agents work on multiple tumor types and if data is available that shows that lives can be saved by a new treatment it can take years for the FDA to give approval and in the mean time precious lives can be lost.

An additional 11 cases involving off-label promotions wound up in the hands of the Justice Department during the same period. Last year, for example, Bristol-Myers Squibb Co. agreed to pay the government more than $500 million to settle claims involving a series of alleged infractions, including promoting the drug Abilify — approved to treat schizophrenia and bipolar disorder — for treatment of dementia-related psychosis and for use in treating children.

This shows that the system may be working better than the reports stated; companies who pay $500 million dollar settlements spend a lot of resources to make sure they don’t make the same mistakes twice.  In addition other companies take notice and change their practices to avoid fines as well.

As is often the case in an election year, the GAO is more than happy to write reports that shed a unfavorable light on the administration especially if the president is from a different party than the party that controls congress.

It wouldn’t hurt the FDA to increase the size of DDMAC, the office at the FDA that reviews advertising but with more and more drugs going off patent that may not be a long term necessity. 

Senator Grassley’s chief concern is that Government takes too long to issue citations on off label promotion.    These are not traffic tickets, many of the citations can fall into “grey areas”, because of the complexity of labeling, and the fact that false claims equal huge fines, the FDA is entitled to taking their time to ensure they have all the facts correct, prior to moving towards citation (I admit seven months is too long, but perhaps three months is reasonable, but as is much with these types of reports the real number is probably closer to three months than seven)

Until we have evidence that there is actual patient harm or that the activity is actually happening, a slow and steady process might not be such a bad thing.   

When the GAO does get around to finalizing their draft “report” we will make it available here.

AP Story: FDA Faulted over unapproved uses of medications

MSNBC Reprint: Little monitoring for 'off-label' drug marketing

NLARX: Singing the Blues in New Orleans

Several months ago National Legislative Association to Reduce Prescription Prices (NLARX) announced that their satellite symposium at the National Council of State Legislators (NCSL) in New Orleans held today, July 25, 2008 was going to be a discussion on legislative victories they had won in New York, Massachusetts and Washington, DC.

The agenda has changed in the last few weeks to:  A Shot in the Arm: New Lessons in the Battle to Save Drug Costs and Protect Patients: . Now the discussions are on the success of the panel from last year’s meeting (that’s right they had a good time last year so why not talk about it) and the 3-state New England collaboration to provide objective drug information to prescribers ("academic detailing"), legislative campaigns to ban gifts to doctors and license drug sales reps, and the latest news on federal legislation and Congressional investigations into drug marketing tactics  (apparently they want to discuss their victories in important states of Maine, New Hampshire and Vermont).

If one was going to discuss victories perhaps they would have some victories to discuss, but not this group. I guess if you have booked the room and the speakers you might as well make the best of it.

I once had a friend who went to the French War College in Paris. Another military friend made light of the fact that what they were going to learn about famous French military victories would be a short list (actually you type it in Google and it takes you to perhaps you made a mistake (see link). 

This conference promises to be the equivalent of studying famous French war victories; a lot of pride but not much for wins.

Perhaps the legislators around the country are finally waking up and realizing that pharmaceutical and device companies are not the “villains”, that they bring jobs to our states, and new medicines that eventually save lives.

At the beginning of this year dozens of bills were introduced throughout the country in state legislatures proposing everything from banning gifts to physicians (and gifts means all work), to restrictions on prescription data and disclosure laws.  Not a single state took them up (DC is a city with a corrupt city government making deciscions by local favors - you pass my bill, I will pass your bill, you want a street paved... to get a licensing of sales reps bill; “I think I will yawn”).   Massachusetts is still considering a bill that the house passed, that would codify the PhRMA code, which is a reasonable proposal by any strech of the imagination, and the provision for academic detailing is an earmark for University of Massachsetts School of Medicine not much competition or transparency here.

Fortunately, there is a Latin phrase that is my favorite in working with state legislatures and that word is Sine Die roughly translated (without a confirmed date, end of session, all open bills are dead).  At the end of every legislative session in most state legislatures they end with the two word ending “Sine Die”.

So, I am sure there is much to learn in their confernce about what could have been and why we all need “academic detailing.”  But in the end it is SINE DIE this year to all those really bad ideas.

Part of the NLARX invitation includes “Be sure to stay over Friday night so you can attend our event and the closing extravaganza featuring Cajun Zydeco music and much more”; at least they get to party to the Blues this year.  (Hey I thought legislators couldn't party, can you imagine if this was a physican meeting with a "closing extravaganza featuring Cajun Zydeco music and "much more"   --- NLARX would make announcements that because of the influcence of Zydeco music and "much more" it would be the end of medicine as we know it)

Sine Die

Patient Assistance Programs -- Free Enterprise at Work

In a world of bad news for pharmaceutical companies one item crossed my desk that deserves some note.  Patient assistance programs are working and quite effective.    Astra Zeneca recently released a survey of how people learned about their patient assistance programs.  In all they received over 12,500 calls.  About half stated that they were drawn there either by referrals from their physicians (35%) or through a brochure delivered at the physician’s office (14%).

In 2007 AZ helped nearly half a million people fill 2.8 million prescriptions resulting in $500 million in savings to patients and families.

If the doctors were not informed, the patients would have never received these medicines.   If their rep had not stopped by and dropped off the brochures or informed the doctor, the patients would not have known and not been helped.

Every major pharmaceutical company has a patient assistance program; each year they give away billions of $ to needy patients across the country.  In an era of discussion around patients not getting the medication because they can’t afford them, companies and private industry has set up systems to help needy patients.  Perhaps more attention should be paid to these types of programs which cost very little to the taxpayer and help countless patients.

For links to patient assistance programs:

This is a clearing house of patient assistance programs:

Multiple Company Clearing Houses:

Partnership for Prescription Assistance

Needy Meds

RxAssist

Biotech Companies:  RxHope

Several Key Companies Programs:

Astra Zeneca Patient Assistance

Novartis Patient Assistance 

Merck Patient Assistance

Eli Lilly Patient Assistance

GSK Patient Assistance

Roche Patient Assistance

Genentech Patient Assistance

Johnson and Johnson Patient Assistance

Takeda Patient Assistance

Sanofi- Aventis Patient Assistance

Abbott Patient Assistance

BMS Patient Assistance

Schering Plough Patient Assistance

Massachusetts S2660 -- Time to Encourage the State Senate

Today the Boston Globe reported that House OKs healthcare bill without ban on gifts

The Massachusetts State House passed the comprehensive medical reform bill without the ban on “gifts” to physicians.  They also delayed until 2009 the provision against the use of prescription data.  The state house also voted down an amendment that would have restored the original language of the State Senate bill.

The proponents of the “gift ban” are still trying to get the state senate to override the house and keep the “gift” ban.    One group Health Care for All, stated “We’re hopeful we’ll prevail and we’ll get a gift ban that may not look exactly what the Senate proposed, but is much stronger than what came out of the House today,”

Today if you live in the commonwealth of Massachusetts now is the time to let your State Senator know that you support the language of the State House for the Medical Reform Bill and the changes that they made for the gift ban. 

These changes represent responsible legislation and will continue to foster communincation to bring state of the art medicine to the citzens of Massachusetts.

Attached is a link to State Senate's contact information:

Link to: Massachusetts State Senate

Massachusetts Current Version of Bill: Massachusetts house bill 4974

Boston Globe Article: House OKs healthcare bill without ban on gifts

Massachusetts S2660 -- Gift Ban Goes Bye Bye

In a move that shows legislators in Massachusetts understand the need for manufactures and physicians to continue to work together to bring state of the art medicine to the patients in Massachusetts: A ban prohibiting manufactures from giving gifts and meals to doctors was removed from S 2660 by the Joint Committee on Healthcare Financing. The bill is now known as Massachusetts house bill 4974.

The new language includes:

-       Companies are required to adopt a marketing code of ethics, such as the PhRMA and AdvaMed Codes (similar to Nevada law). Section 111N, Chapter 112 (Page 20-23)

o   Training on the Code of Conduct to Employees

o   Annual Audits of Compliance to the Code

o   Policies in Place for Investigating and Reporting instances of Non-Compliance

o   Identification of the compliance officer at the company

-       Includes a ban on the sale of prescription data (identifying doctors or patients). Section 15, Chapter 112 (Page 23-26)

-       It also kept intact the Senate’s proposal for Academic Detailing (where doctors are paid by the state to go out and give talks on evidence based medicine and the benefits of generic drugs). Section 5, Chapter 111 (Page 12-13)

The committee also dropped requirements that drug and device firms disclose consulting and speaking fees to physicians.

Patricia Walrath, House Chairwomen of the Joint Committee on Health Care Financing told the Globe that her committee striped out the gift ban language because pharmaceutical and biotech leaders told law makers it could chill industry-funded educational conferences that bring doctors together with researchers.  “We were very concerned that the Senate language would deny (doctors and researchers) the kind of information they need, she said “One could interpret (the Senate’s Version to mean) they would not be able to get anything.”

The house is expecting to vote on this today.

One person who realy went out of his way to make a difference is Kevin Abt at ResturantsToYou.com, he put in perspective the effects that these types of proposed bans can have on small businesses throughout the country. 

This is a clear victory for the voices of reason, the new PhRMA code covers most of the concerns expressed by legislators and should serve as a model for other states. 

Massachusetts Current Version of Bill: Massachusetts house bill 4974

Wall Street Journal Blog:  Plan to Ban Industry Gifts to Docs Stalls in Massachusetts

Boston Globe: House panel drops ban on drug industry gifts to doctors

Pharmalot: Massachusetts Gift Ban Is Removed From Bill

Medicare Bill 2008: In Override

Last night Congress overrode the President’s veto of the Medicare Re-imbursement bill 70-26.   Earlier in the day the house had also overridden the veto by 383-41.

Without the override, physician reimbursement would have been cut by 10%; the bill gives physicians a 1.1% increase in their fees.  The bill was passed for 18 months, giving the new congress and president enough time to work out a compromise the next time around.

It is a curious veto for the president, I am not sure what he had hoped to accomplish in this Veto.

President Bush states:

“I support the primary objective of this legislation, to forestall reductions in physician payments,” Bush said in his veto message today. “Yet taking choices away from seniors to pay physicians is wrong.”

This override moves the debate to 18 months from now, when the cut will be 20%.  Passage of this bill is a tribute to the hard work of doctors and seniors to see it get passed.  Senator Baucus deserves a lot of the credit, having kept the debate and the size of the bill to a minimum.

This bill was the legislative vehicle that Senator Grassley was hoping to amend for the Physician Payment Sunshine Act, perhaps next year the environment will be a little less charged.

Bloomberg: Congress Overrides Bush's Veto on Medicare Payments

Wall Street Journal: Congress Overrides Medicare Veto

New York Times: Congress, Overriding Bush, Blocks Pay Cut for Doctors

Policy and Medicine: Medicare Bill 2008: Update

ACCME Responds to Senator Kohl

In a detailed letter, Murray Kopelow, MD Chief Executive of the ACCME responded to the request for information from Senator Herbert Kohl, WI Chairman of the Senate Select Committee on Aging.

In the letter the ACCME provides:

·         Background about ACCME

·         A copy and written description of the accreditation process for CME courses

·         The criteria that the ACCME uses as part of the accreditation process, regarding the scientific validity of course content

·         The mechanisms the ACCME has in place to ensure that no undue influence by industry is being exerted through courses.

·         Further plans the ACCME has in place to develop such mechanisms

The ACCME letter is a good reference for how the accreditation system works. The system of CME has changed tremendously over the last five years to ensure the elimination of commercial bias.  The document submitted is very thorough and should answer the questions that the Senator was looking for.

Letter from Senator Kohl

Response from ACCME

Reference Articles

ACCME Senator Kohl Get's in the Act

Letters from Senator Grassley: Gone Fishing on the APA

Every summer Iowa, which is full of small lakes, is full of fisherman, boys and dads desperate to catch the next big one.  Often, when one catches the “big one” they get their picture in the local paper and bragging rights for some time.

But what if you went fishing at Fisher Lake or Big Woods Lake in Cedar Rapids Iowa, would you call the news papers ahead of time and say “Hey, I am not sure if there is a big fish in this lake, but if there is one, I am going to catch it.”  Would the Cedar Rapids Gazette print this story? I doubt it. 

Well, it seems that summer is also a time for Senator Grassley to go fishing as well, this time for any fish he can find. Rather than waiting to catch the fish, he is sending copies of pre fishing reports (exploratory letters), to the New York Times which is now in the business of writing pre-fishing articles and they are more than happy to oblige him with a story about his fishing expedition.  Psychiatric Group Faces Scrutiny Over Drug Industry Ties.

Now, usually you wait until you at least have a bite before you go off and talk about how you almost caught the big one, but not in this case.

In this case, Senator Grassley is taking on the American Psychiatric Association in a letter apparently asking for a full accounting of all the commercial support they have received over the last few years and their incoming president Alan F. Schatzberg, MD, the chairman of Psychiatry at Stanford University. 

In his letter to the APA, Senator Grassley states: “Based on reporting in the New York Times”, I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions.”  Charities Tied to Doctors Get Drug Industry Gifts

The Times failed to quote the beginning for their article “Based on reporting in the New York Times”

(Wait a minute, this is a hall of mirrors: Senator Grassley sends the New York Times press releases about the evils of doctors and organizations, the New York Times prints the senators stories, then he can say in letters “Based on articles in the New York Times” and get that same sentence quoted again in the New York Times......)

The Senator wants an accounting of industry funding that pharmaceutical companies and/or foundations established by these companies have provided to the American Psychiatric Association (APA)  (the term “industry funding” means any transfer of value from a pharmaceutical company, included but not limited to grants, donations, and sponsorship for meetings or programs, ect.) from January 2003 to present.

He has requested this in chart form (to make it easy for the reporters to understand), by annual amount including – year, name of company, amount of funding and reason(s) the funding was provided.

He also requested a description of their policies for accepting industry funding, and whether or not the APA allows companies to place restrictions or provide guidance on how the monies will be spent.

If there were any restrictions, then provide the restrictions and guidance for each transfer of value.

So why go after the APA.  His investigation of Psychiatry has been ongoing involving 20 intuitions.  It seems to be centered on two types of drugs: pediatric indications for ADHD and experimental therapies such as mifepristione (RU-486) for depression.

The Times story noted that Psychiatrist make significantly less than other specialists, about $8,000/year more than a Internist, and they used the data from Vermont disclosure laws to justify going after psychiatry as they are currently heavily involved in consulting and speaking.

The APA has sent Email to APA Members that they decided in March to review the whole concept of commercial support.

Could part of this be that the Senator was embarrassed that Dr. Schatzberg has done nothing unethical in the sight of Stanford, the APA, and NIH.

I am not sure that shaming medical associations on the pages of the New York Times before you get the facts, serves anyone other than the egos of those involved.  Having worked with dozens of medical societies, it is clear that their leadership are filled with dedicated physicians who strive to do the best for their patients.  Challenging these associations ethics before you get the facts is no way treated the years of hard work and dedication they have exibited.

There is something unkind about this tactic.  His colleagues in the senate should ask for these types of inquires to be conducted in a civil tone, getting the facts prior to press releases and public shaming.   

And perhaps we can get back to catching some real fish in Iowa.

Important Links:

Senator Grassley:  Letter to the American Psychiatric Association

American Psychiatric Association:  Email to APA Members

WSJ Blog: Grassley Targets Psychiatric Association for Industry Ties

New York Times: Psychiatric Group Faces Scrutiny Over Drug Industry Ties

New York Times Charities Tied to Doctors Get Drug Industry Gifts (Charity Article June 2006, Quoted by Senator Grassley):

Pharmalot: Grassley Probes Psychiatrists Over Ties To Pharma

Policy and Medicine: Letters from Senator Grassley: A Scarlet Letter