Longtime drug safety watchdog Rep. John Dingell and other members of the powerful Energy and Commerce Committee today introduced a new version of the comprehensive Drug Safety Enhancement Act, which would strengthen the FDA and close critical gaps in the safety of the U.S drug supply.

A drug safety hearing of the E&C Subcommittee on Oversight and Investigations tomorrow will provide an early opportunity to look at the ways this new bill addresses some of the complex risks that spring from an increasingly fractured and global drug supply chain.

Brought by Rep. Dingell, Ranking Member Henry Waxman, Health Subcommittee Ranking Member Frank Pallone, and Oversight Subcommittee Ranking Member Diana DeGette, the Drug Safety Enhancement Act, comes less than a month after the agency told industry, consumers and policymakers at the After Heparin conference that it needed to make bold updates and obtain new regulatory tools to keep pace with the expansion of the drug supply. The bill reflects past agency priorities and recommendations, as well.

According to a Committee statement, the bill:

• gives the FDA important new enforcement tools it’s been asking for, including recall and subpoena authority
• boosts inspections by generating funds for GMP inspections and requiring parity between inspections of US and foreign drug-making plants and suppliers
• builds a higher barrier between unsafe drugs and US medicine cabinets, prohibiting drugs from sites that cannot prove or have refused, failed, or falsified inspection from entering the country
• improves tracking by establishing a registry and unique ID numbers of all drug facilities and parties supplying the US, both foreign and domestic

“A few years ago, thousands of American lives were jeopardized by contaminated heparin stock imported from China,” said Rep. DeGette in a statement. “As pharmaceuticals and their ingredients are increasingly imported from the global marketplace, we must ensure our families can trust the medicines they rely upon by empowering the FDA.”

“We must address the deficiencies uncovered by recent recalls,” said Rep. Dingell. “The Drug Safety Enhancement Act is a strong and effective response to the troubles we face with an increasingly global and complex drug supply.  I look forward to working with my colleagues on both sides of the aisle, consumer advocates, and the regulated industry to ensure we address the safety of the nation’s drug supply in a meaningful way.”

For updates on drug safety legislation and news, follow SafeRxWatch on Twitter.

For summaries of previous drug safety legislation, a consumer survey on drug safety, and other resources, visit Community Catalyst and Pew Prescription Project’s Securing a Safe Drug Supply.

–Kate Petersen, PostScript blogger

Though Congress adjourned Wednesday, the House Oversight and Government Reform Committee went ahead and heard yesterday from two Johnson & Johnson/McNeil executives and the FDA over the ‘phantom recall’ of defective adult Motrin earlier this year.

To refresh, J&J has been in the news quite a bit this year, primarily for its recall of more than 135 million bottles of children’s liquid medications in May after numerous consumer complaints and an FDA inspection of the plant in Fort Washington, Pennsylvania turned up raw materials that were contaminated with gram-negative bacteria.

At the hearing Thursday, J&J CEO Bill Weldon admitted that the company did not notify FDA that it was purchasing product in an April sweep of stores now known as the phantom recall. Emails obtained by the committee revealed that J&J contractors were instructed to buy up deficient bottles of Motrin while acting like regular customers so as not to alert employees or the public.  Both Weldon and Consumer Group Chairwoman Colleen Goggins backpedaled on the “unfortunate language” and poor quality and notification systems, things that should have been done differently. There was a lot of Won’t Happen Again.

But these recalls were not just a case of unfortunate language and isolated mistakes, FDA Deputy Commissioner Joshua Sharfstein said: J&J had a big systemic quality problem.  The FDA inspected every McNeil plant at least once in the last year, and every one was found to have “inspectional deficiencies,” which the agency has been working with McNeil to clean up.

Weldon, too, highlighted the cooperation with the agency on fixing the quality systems and said that the children’s medicines recalled earlier this year would be back on shelves next week.

But members of the committee were unmollified. Ohio Rep. Dennis Kucinich said that there was a pattern of concealment, and was incredulous when Goggins maintained she was unaware of a series of emails discussing the advantages of the “soft market withdrawal” of the Motrin over a regular recall.

And Missouri Rep. Lacy Clay grew impatient when he tried to get a straight answer on why the company didn’t even get to close to meeting an FDA rule that requires companies to notify the agency within three days of any suspected contamination, irregularity or other change in a drug:

Clay: You can twist my words if you want, but why didn’t you report it within three days?
…
Goggins: I don’t know which instance you’re talking about. If we did not sir, we should have.

Clay: Any of the incidents! You didn’t report it in a timely fashion, within three days.

Weldon: Sir if–

Clay: So why didn’t you? Simple question.

Weldon: Yes, that I cannot answer. I would say though in all instances, in some instances, I know that we did. I don’t know the specific instance. If we did not, it was a mistake on our part and we should have.

The FDA’s Sharfstein didn’t get a free pass, either. Though he said there was no evidence that FDA was aware of or had condoned the phantom recalls, Ranking Member Darrell Issa tore into the deputy commissioner for requesting recall authority, waving a binder of inspection reports from the Fort Washington plant at him and suggesting FDA should have shut the plant down instead of asking for more authority.

But Sharfstein made a clear and compelling case for why the agency should have mandatory recall authority: The agency currently cannot tell a company how to recall product, he said, or influence the timeline or execution of a recall, and if a company refuses to recall a product FDA believes to be unsafe, the agency can only take product off shelves through complicated and time-intensive court channels (you can read his full prepared testimony here).

“The event of the phantom recall raises important questions about the current voluntary recall system,” he said. “In this case, if FDA had had the authority simply to order a recall to be done in the right way, I do not believe these events would have occurred.”

Two bills before Congress now, the Drug Safety and Accountability Act and a House bill introduced by Committee Chairman Edolphus Towns, would give the FDA that authority.  A third draft bill in Energy and Commerce would give FDA the same power.

Congresswoman Eleanor Norton from D.C. agreed with Sharfstein’s assessment that the current voluntary system depends totally “on companies providing accurate and complete information” to the FDA:

A voluntary system would assume all that to be the case. But I must say, it makes the same kind of assumption that was made for 10 years about the financial system, that voluntarily letting them go without regulations will do it.

In the same way, this voluntary recall notion is not only an oxymoron, I don’t see how we can continue to abide it, and expect companies to act any way but the way people do: to protect themselves, to protect their shareholders. And the only way to pierce that is with some form of regulation. If we haven’t learned that from financial reform, and now we’ve got to learn it through children’s medicines, we’ll never learn it.”

You can watch the full hearing at C-SPAN.

–Kate Petersen, PostScript blogger

In the spirit of covering spirited drug safety hearings, we feel we ought to point out (if a little belatedly) Rep. Steve Buyer’s animated exchange on counterfeit drugs during an Energy and Commerce Health Subcommittee hearing on antibiotic resistance in farm animals in July.

Buyer (R-IN) has established for himself a reputation as a watchdog on counterfeit drug issues. In 2008, he joined with Rep. Jim Matheson (D-UT) to introduce the Safeguarding America’s Pharmaceutical Act, which would require the federal government to establish a track and trace system so that drugs would have a traceable pedigree from the manufacturer to their arrival on pharmacy shelves. The bill would also establish protocol for counterfeit drugs identified by FDA at the U.S. border.

Though Rep. Buyer has announced he’s retiring at the end of this term, he made clear during the antibiotics hearing that he intends to introduce more counterfeit legislation alongside colleague and drug safety advocate John Dingell.

Below are highlights from this portion of the hearing. The full preliminary transcript can be found here.

Mr. {Pallone.} Next is the gentleman from Indiana, who has 8 minutes. Mr. Buyer.

Mr. {Buyer.} Thank you very much. Dr. Clifford, I have a question that deals with adulterated, counterfeit, knockoff drugs. We have a problem in our country, and countries around the world are challenged by this. Do you see any escalation or any evidence of adulterated counterfeit drugs in animal health?

Dr. {Clifford.} Congressman, since this really falls under FDA’s jurisdiction, I would have to turn to them to answer that question.
…

Dr. {Sharfstein.} For animal health, I think we are going to have to get back to you. I am not prepared to answer that. I have not heard of a significant counterfeit problem in the United States but I want to make sure and get back to you.

Mr. {Buyer.} You know, as our problem is growing, it is only time before it migrates. It is going to follow the money, right? Bad guys follow the money. And that is why I asked the question.

I want to thank the FDA for continuing the blitzes that you are doing at international mail facilities, so thank you for doing that. You are trying to “get the word out” to Americans that if you go on the Internet and you think that that is an approved website to order your pharmaceutical products, that you are really playing Russian roulette with your life, and so thank you for keeping these blitzes going and trying to get the word out. I noted in your testimony when you were with us in March, you had in your testimony, “Protecting Americans from unsafe or contaminated drugs is not just an important responsibility of the FDA, it is our core charge.” Do you agree with that today?

Dr. {Sharfstein.} I do believe that. I think it is one of the reasons that FDA—

Mr. {Buyer.} So–

Dr. {Sharfstein.} –was established.

…

Mr. {Buyer.} You also then in your testimony talked about FDA must adopt a new approach. Now, I think when you talked about your new approach, also you were concerned about the production, i.e., raw ingredients, that are used within our supply chain for which people are buying at retail outlets within the gold standard of our own country. So ensuring that we maintain that gold standard, you are putting your eyes on that supply chain and production. I don’t have any problems with that. I think that is wonderful. I think the Administration is doing what it is supposed to do. I applaud you with regard to your striking the agreements with other countries, putting more inspections on other soils. That is awesome.

…Now, as we are doing this, we have got both of these going on at the same time, is we are trying to then do our electronic pedigree, and Mr. Dingell has a bill, and we are going to do work and do this electronic pedigree, but let me tell you what I was bothered about what I read in the Miami Dade about your last blitz. I think it is great. Like I said, you are doing the blitz. You did a 3-day blitz. You did everything you were supposed to do, your coordination with Customs, Border Protection, thousands of pieces of foreign mail. You X-rayed them. You separated them. You identified them, the suspicious pharmaceutical products. You ID’d them. You showed how many of them were counterfeit and knocked off, and then you sent them back.

America has to be shocked, and the counterfeiters have to be excited that America is a place where you can counterfeit your drugs, send them to America, steal people’s money, and the American government will send the counterfeit drugs back to you so you can then send them to someone else that you can steal more money from. This is like one of the dumbest policies I think we have in this country…

I know you have got to be uncomfortable with that as a policy. Are you?

Dr. {Sharfstein.} Yes. I mean, I have spoken to some of the inspectors who are, you know, as frustrated as you are.

Mr. {Buyer.} All right. Now, if you are willing to step into a new–and that was your testimony that you gave to us in March, that you embrace and wanted to adopt a new approach with regard to the raw ingredients, through production and distribution always to U.S. consumers, I think I have an opportunity. I think, Mr. Dingell, we have an opportunity to help protect America, and that is embrace what the FDA is saying here, Mr. Dingell, and let us figure out how we can destroy these when they are identified, when your inspectors identify them. Let us not send them back to the counterfeiters so they can continue to rip off people. You know, Doc, come on, they are preying upon the most vulnerable of our population, which is awful. Would you be willing to work with Mr. Dingell and I to come up with a policy here that can give your inspectors the ability to destroy these counterfeit, knockoff, adulterated drugs?

Dr. {Sharfstein.} Yes, and I believe we have been already starting that process by working with your staff and Congressman Dingell’s staff on this issue.

Mr. {Buyer.} All right. Well, I want to be as proactive as we possibly can. John Dingell, to his credit, started this a long time ago with his paper pedigree, and he has always had a great interest. It goes all the way back many years into the 1970s, and I applaud what he has done. I think he has got to be pretty shocked on where America is today compared to where we were in the 1970s, and as a policy and I know you adopted this, I was just as frustrated with the last Administration but I am embracing your spirit, and if we are able to move ahead, Mr. Dingell, I want to join with you today and I want to work with the FDA and I want to resolve this matter. I want to yield to the chairman for a second.

Mr. {Dingell.} I thank the gentleman. He is most kind to me, and I want to thank him for the kind comments he has made about me. I want to assure him that my assurances of the last Congress, I would be happy to work with him, and I happen to agree with the gentleman about the problem of imports, about tracing pharmaceuticals and other drugs, and I am pleased to report to the gentleman that very shortly we will be circulating a draft for comments about pharmaceutical safety, and I hope that the gentleman when that occurrence happens that he will look at it with sympathy and I look forward to working with him because he is a valuable member of the committee, and I thank him.

Mr. {Buyer.} I thank the gentleman. The last, can I do this piece of math? Thirteen-

-

Mr. {Pallone.} The gentleman’s time has expired, but all the love–

Mr. {Buyer.} I ask unanimous consent for 30 seconds.

Mr. {Pallone.} Yes, with all the love and bipartisan here–

Mr. {Buyer.} God bless you.

Mr. {Pallone.} I certainly don’t want to stop the gentleman.

Mr. {Buyer.} Thirteen international mail facilities, on average 35,000 are pharmaceutical packages, times 365 days, that is 1,666,075 packages a year. If 80 percent are counterfeit, adulterated or knocked off, that means there are 132,860 pharmaceutical packages that are coming into the country that are either adulterated, counterfeit or knockoff, and people are taking these and they are not metabolizing in the body in ways in which as doctors you intend. With that, I yield back.

–Kate Petersen, PostScript blogger

It’s been a rough couple of weeks for GlaxoSmithKline. On the eve of last week’s FDA hearings to decide whether its former best-selling diabetes drug Avandia should still be sold, the New York Times broke news of the company’s efforts to conceal internal studies showing the drug posed a much higher risk of heart attack than its main brand-name competitor, Actos. Yesterday, we learned that a member of the FDA panel received payments from GSK. And, today, the FDA put the brakes on a new trial to compare Avandia with Actos (hat tip: Pharmalot).

But buried in the onslaught of Avandia news (perhaps on purpose?) was the PR-challenged drugmaker’s announcement last Friday that “a small number” of Advair diskus inhalers, (used to treat patients with asthma and chronic obstructive pulmonary disease) stolen from a company warehouse had made their way into pharmacies. GSK’s announcement was followed by a stern FDA warning to consumers, pharmacists, and wholesalers to cease use of the stolen inhalers, which are identifiable by lot numbers.

This story is a troubling reminder that we do not have strong systems in place in this country to ensure our drugs have traveled legitimate and safe routes during distribution. As Adam Fein points out in yesterday’s Drug Channel blog, these stolen products ended up on pharmacy shelves due to negligent purchasing. Someone involved in the distribution of these inhalers purchased diverted products from a bad actor, either knowingly or by not adequately verifying product provenance.

We need strong federal regulation requiring manufacturers, wholesalers and pharmacies to track drugs during distribution and verify products’ distribution histories, also known as “drug pedigrees.” A robust federal tracking regulation with strong drug pedigree standards would help protect consumers from unsafe products. A number of state pedigree laws exist but vary in strength. Two bills have been introduced in the House that would establish federal drug tracking systems:

H.R.2726: Counterfeit Drug Enforcement Act of 2009 (Tim Fagan Law)
Sponsors: Rep. Israel, Rep. Ackerman

H.R. 5839: The Safeguarding America’s Pharmaceuticals Act of 2008 (expected to be reintroduced this session)
Sponsors: Rep. Buyer, Rep. Matheson

We hope this latest disturbing incident serves as another stark reminder of the urgent need for Congress and the FDA to take action to address the safety gaps in the drug distribution system. As for GSK and other manufacturers—they need to beef up their security, let the public and FDA know immediately when it is breached, and embrace proposed new tracking systems.

For more on drug safety and the importance of developing a prescription drug tracking system, visit the Pew Prescription Project’s Securing a Safe Drug Supply.

– Kathy Melley, Director of Communications

Two recent headlines highlight the need for a federal electronic track-and-trace system for prescription drugs.

Last week, a Baltimore pharmacist was sentenced to 57 months in prison for making fraudulent claims and misbranding hundreds of thousands of bottles of drugs from an unlicensed supplier. According to the FDA Office of Criminal Investigations, an inspection in 2008 revealed more than 200,000 bottles of misbranded drugs in Pamela Arrey’s Medicine Shoppe, as well as drugs that had expired, or had altered labels. Arrey’s rebranding schemes included metformin, a diabetes medication, and gabapentin, an anti-seizure medication.  (See the FDA press release here.)

And FiercePharma has just released its Top Ten list of pharma cargo thefts by value in 2009-2010. Atop the list was March’s headline-making $76 million heist of antidepressants and other drugs through the roof of an Eli Lilly plant in Connecticut. But it is only the most high-profile case in a growing trend: Pharmaceutical cargo theft has quadrupled in the last four years, according to Freightwatch International, which tracks cargo theft issues.

FiercePharma’s list and Arrey’s conviction are reminders of the risks posed to patients when improperly sold or stolen pharmaceuticals end up back on pharmacy shelves.

Cargo theft and misbranding schemes like Arrey’s highlight the need for a federal electronic track-and-trace system, which would establish a unique electronic ID tag for each medicine bottle so that drugs can be traced back to their original source and verified at each transaction point along the supply chain, from the factory to the pharmacy shelf.  Congresswoman Rosa Delauro (D-CT), who chairs the House subcommittee on FDA appropriations, emphasized the importance of such a system in her Chairman’s Mark last week, and federal track and trace legislation has been introduced in previous sessions of Congress.

For more on drug safety and the importance of developing a prescription drug tracking system, visit the Pew Prescription Project’s Securing a Safe Drug Supply.

–Kate Petersen, PostScript blogger

In his health care reform proposal to Congress and the nation revealed today, President Obama has included requirements for pharmaceutical and medical device companies to disclose payments to health care providers and hospitals. These ‘Sunshine provisions,’ modeled after a bill introduced in the Senate in 2007 by Senators Herb Kohl and Charles Grassley, have bipartisan, bicameral support, and were included in the health care reform bills passed by both the House and Senate this winter.

Here’s the language:

To prevent conflicts of interests and insure full transparency and information for patients, the Act requires all drug companies, device, and medical supply manufacturers to fully disclose and report any gifts they make or financial arrangements they have with doctors, a physician practice or group.

The proposal, released ahead of a much-awaited bipartisan health care reform summit at Blair House this week, reflects a growing national consensus about the need for robust transparency of the financial relationships between providers and the pharmaceutical and device industries, including recommendations by the Institute of Medicine and the Medicare Payment Advisory Commission.

The President’s health care reform proposal also requires pharmacy benefit managers to disclose information about negotations and drug pricing deals they make, a component of the original House bill passed in November.

President Obama’s proposal goes beyond the Senate bill on prescription drugs in two other important ways:  closing the Medicare Part-D ‘doughnut hole,’ and banning pay-for-delay settlements that keep drug costs artificially high.

By closing the doughnut hole, the President’s plan would save the 8 million seniors who exhaust their prescription drug benefits each year an average of $4,080 a year by 2020. Like today, seniors will still have a 25 percent co-insurance obligation until ‘catastrophic’ coverage kicks in, unless they qualify for low-income subsidized coverage.

The proposal also grants the Federal Trade Commission the authority to police drug company patent settlements for “collusion” to keep generics off the market. FTC estimated that such a reform would save $35 billion over the next decade, and Obama’s proposal would give FTC the authority to prevent these settlements unless proven to increase competition.

–Kate Petersen, PostScript blogger

In her testimony before the House Energy and Commerce committee on health appropriations, HHS Secretary Kathleen Sebelius called for $101 million of FDA’s 2011 budget request to be used for a “medical product safety initiative” to increase inspections and “invest in tools that will enhance the safety of increasingly complex drugs, medical devices, and biological products.”

We are glad to see the Secretary recognizing the need for increased inspections –  the lack of foreign inspections is a  problem highlighted recently by FDA itself and the GAO, which found that FDA is able to inspect just seven percent of prioritized foreign drug manufacturing sites every year. This, despite evidence that foreign India and China alone produced close to 70 percent of the global supply of active drug ingredients in 2007 – up from just under half of the APIs three years before.

Doing the math, that means plants making U.S drugs overseas may wait well over 10 years between FDA inspections, while domestic plants are inspected every 2.7 years on average.   The rate of inspection within China is even lower. If unchanged, it would take nearly 50 years to inspect all 700 or so FDA-registered Chinese drug-manufacturing sites.

Recent increases in budget appropriations for FDA have allowed the agency to begin to build its foreign inspections program, as well address structural problems at the agency like understaffing and IT capacity.  But serious structural problems affecting the agency’s ability to regulate drug manufacturing and importation remain.  And considering the growth rate of foreign manufacturing plants and how thinly resources must be stretched.  The increased appropriations the Secretary recommends will likely still be insufficient to bring foreign inspection up to speed with domestic inspection rates.

One way to help correct for this would be to consider a user fee system as proposed in legislation introduced in both the House and Senate in the current Congress. The agency already employs user fees with drug manufacturers during the approval process, and with food and drug companies whose manufacturing violations require re-inspection. A similar user fee for general Good Manufacturing Practice (GMP) inspections inspections would help protect consumers.

Inspections alone are not the solution. FDA must find better ways to predict risk. And the agency is taking steps. For example, at the border, the agency uses  PREDICT, a new web-based risk-based assessment system that incorporates inspection histories, counterfeit risk, and environmental influences. But such a system could also be used earlier in the inspection process, to target overseas manufacturing inspections before risky products ever get shipped or unloaded at the docks.

–Kate Petersen, PostScript blogger

Will CME providers be included in the Sunshine provisions of health care reform? The Wall Street Journal looked at the question recently. The final House health reform bill includes CME providers and other third-party medical groups among the covered recipients whose payments from the pharmaceutical and medical device industry would be publicly disclosed—language referred to as the Physician Payments Sunshine provisions. The Senate Finance bill that is being merged now with the HELP committee  also contained Sunshine provisions, but did not include third-party groups.

Yet representatives of industry-backed CME in Washington whom the Journal spoke to seem to understand that good transparency means broad transparency, and that broad transparency is becoming a requisite for credibility in the medical education industry.

Indeed, since the Sunshine Act was introduced in January 2009 as a stand-alone bill that would require drug and device companies to disclose all payments to doctors and others, acknowledgment of a need for national medical transparency standards has gained wide acceptance. The Institute of Medicine and the Medicare Payment Advisory Commission have both recommended that third-party medical groups like CME providers be among those whose payments from industry should be disclosed; the IOM called for an end to all company support of such education programs within two years. As the Journal points out, companies such as Pfizer and GlaxoSmithKline have stopped direct support of for-profit third-party CME providers.

–Kate Petersen, PostScript blogger

In the afterglow (or for some, aftermath) of the election, PostScript thought it was worth scanning the federal policy horizon for any Rx out there.

And it’s hard to say anything about prescription drug policy in the next Congress without first talking about health reform.

With an early break from the gate, Senate Finance Committee Chair Max Baucus (D-MT) released a white paper last week entitled “Call to Action: Health Reform 2009.” The paper was the first look at an issue that lawmakers and President-elect Obama have both named as a priority when Congress reconvenes. It included provisions for comparative effectiveness, coverage-guarantee for those with pre-existing conditions, and would allow people age 55-64 to buy into Medicare early.

While passing health care reform is going to take broad consensus, and others such as Sen. Edward Kennedy (D-MA) and President-elect Obama are working on comprehensive plans of their own, we were encouraged to see that the Baucus paper recommends public disclosure of the financial relationships between industry and the medical profession. The paper referenced the recommendations MedPAC approved last week (see our earlier post) as well as S.2029, the Physician Payments Sunshine Act, though it doesn’t recommend specific reporting thresholds as MedPAC and PPSA have.

And right after Who Will Be the Next Commish, a little game being played at all the right blogs and Beltway dinner parties this season, we see two major FDA questions facing the Congress in its next term:

Q: With drugs coming from everywhere on the planet, how do we make sure they are safe enough to go into American medicine cabinets?

(Probable) A: The FDA Globalization Act. Ever since the heparin-from-China scare of 2008, interest in having a better handle on where our drugs are coming from and a bill that would shore up oversight, require new country-of-origin labeling, provide more resources for inspections of foreign manufacturing plants, and grant the agency subpoena power many other federal agencies charged with protecting the public already have. Both a House and Senate version were introduced in 2008.

Q: What happens to biotech drugs after the patent runs out?

(Right now) A: Nothing, and that’s an expensive answer both for consumers and the future of the drug pipeline, as R&D turns more and more to biologic therapies. Currently, four draft bills on the creating a pathway for biogenerics (also called “follow on biologics”) are circulating. The version introduced by Rep. Henry Waxman (D-CA) is widely considered to be the most consumer-friendly.

Only 64 days till the 111th is sworn in, so stay tuned – we sure will.

This week, House Energy and Commerce Committee Chair John Dingell (D-Mich) and Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) sent a letter to the FDA asking about just how and why the agency chose non-profit EthicAd to partner on the creation of the “Be Smart About Prescription Drugs” website, launched last month to help consumers navigate drug ads.

In September, we had some questions of our own about EthicAd’s mysterious funding sources and close ties to Shaw Science Partners, a pharmaceutical marketing company with a long list of Big Pharma clients.  We broke news of Shaw Science Partners and EthicAd’s office- and phone-sharing arrangement here on Postscript, and look forward to hearing of the agency’s reply. 

And the latest joint probe of the Senate Finance Committee and the Special Committee on Aging, Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) are looking into industry payments received by Columbia University cardiologist and stent entrepreneur Martin Leon and other Columbia researchers at the Cardiovascular Research Foundation.  The probe seems to center around the CRF’s industry–sponsored device conference, Transcatheter Cardiovascular Therapeutics, and Leon’s ties to the sponsoring companies.

Here’s more at Bloomberg.

But it’s only the latest investigation, and if history’s any guide, won’t be the last. With the troubling discovery of piles of undisclosed industry payments an Emory University psychiatrist took from a company whose drug he was testing on the government’s dime, and new revelations about the wag-the-dog marketing tactics used to push Neurontin, editors of the New York Times and Atlanta Journal-Constitution write this week that all this coziness between drug companies and doctors “underscores the need for Congress to pass a bipartisan bill, sponsored by Senators Chuck Grassley and Herb Kohl, that would require drug companies and other medical manufacturers to publicly disclose payments to physicians that exceed $500 a year.” (10/11, New York Times).

The Journal-Constitution went further in its recommendation, saying passage of the disclosure bill – also known as the Physician Payments Sunshine Act – is a “bare minimum,” and that the “culture that has infected drug company sponsorship of academic medicine needs a thorough cleansing,” including a “temporary reduction in the amount of money going into research and continuing physician education.”(10/12, Atlanta Journal-Constitution)

And another editorial in the Arizona Republic this week takes a puzzling non-stand on the PPSA: First they were against, then they were for it? In the end, we’re not really sure. Just like the writers don’t seem very sure whether or not doctors are influenced by pharmaceutical marketing. The verdict?  “Probably not.” Sure, we’d heard the West is a place of fewer words, but this is taking it too far.

The first two editorials were no doubt spurred by the controversy around Dr. Nemeroff’s busy speaking schedule. News came this week that he’s about to get a little less busy – the National Institutes of Health have hit pause on the 5-year, $9.3 depression grant that Nemeroff was heading up at Emory. The AJC says despite his freed up schedule, Nemeroff is still turning down interviews.

And over at A Healthy Blog, RxP’s Kathy Melley looks ahead at what we’ve all been waiting for. Our 401Ks back? Ok, the other thing we’ve been waiting for – the decision from the U.S. Court of Appeals on prescription data-mining bellwether case, Ayotte v. IMS Health.

“The court ruling could have the effect of ratcheting up or down state legislative activity on data mining,” Melley writes, but that “regardless of where the court comes down, there’s a good chance the U.S. Supreme Court may be the final arbiter on this issue.”

Medical students and local physicians will rally at the Harvard Medical School campus today, urging their adminstrators to create better conflict-of-interest policies around pharmaceutical marketing.  According to a press release from the American Medical Student Association, which is capping its National PharmFree Week at the Longwood medical campus in Boston, “Students are asking for involvement in the policy drafting process, increased transparency, mandatory lecturer disclosure and a reasonable timeline for drafting and implementation.”

Check out the AMSA scorecard rating medical school COI policies here.