The HCC, Its Priorities, and Financial Disclosure

The headline on the Healthcare Channel article reads: Did Merck conceal funding to a vocal advocate of Gardasil?

If Merck tried to, it did a lousy job. Its financial connection to oncologist Maura Gillison, the woman who linked the human papillomavirus with a new type of tonsil cancer, is readily available on the Web. The earliest connection we found goes back to a Forbes story, written in 2009. If Merck tried to keep the connection out of the story, it failed.

There might be an earlier mention, but there’s no date on this disclosure: Dr. Gillison, who also has a PhD, apparently spoke at a webinar for the Association of Reproductive Health Professionals. She disclosed that she “receives unrestricted educational grants from Merck and Digene.” 

If you haven’t guessed already, this is yet another dust-up over financial disclosure. The Healthcare Channel apparently was all aflutter that Dr. Gillison hadn’t listed Merck as a funding source when she published an article in the New England Journal of Medicine in 2010. It notified NEJM; the journal investigated, and it decided that Dr. Gillison HAD NOT violated any of its disclosure rules because the financial arrangement had fallen into a “gray area.”

We don’t know why NEJM let Dr. Gillison slide; but we think this is an example where we need to be careful about the generalizations associated with industry and healthcare practitioners' relationships.

The Healthcare Channel wrote: “The Healthcare Channel has exclusively learned that Dr. Gillison was in fact receiving payments from Merck, going back to 2008 that benefited at the least her laboratory, while she was at Johns Hopkins.” Maybe if its writers had surfed the Web for 15 minutes, they would have found what we found.

This is what the Merck Web page says regarding the information it discloses:

"On March 29, 2011, Merck updated its report on payments to U.S.-based medical and scientific professionals who speak on behalf of Merck about our products and other health care issues. These reports include legacy Merck products prior to the November 2009 merger between Merck and Schering-Plough. The new report covers payments made to speakers for the full year 2010. The report provides data for 2,088 physicians and other health care professionals who, on average, participated in 5.9 programs each and earned an average of $1,659 per program…"

Dr. Gillison is not listed. The presumption: She didn’t speak for Merck during 2010.

We all know there is no uniformity among the current disclosure laws, or among the industry members who are disclosing on Web sites. We’ll all have to wait for 2013 for that to happen.

This is what the Forbes article said about Dr. Gillison and Merck: “Gillison spent three years trying to draw Merck's attention to HPV tonsil cancer. Finally, she is working with Merck to design a study to see if Gardasil can affect HPV infection in the throat. Merck admits studying the problem is ‘challenging’ but says the potential is big.”

Here is a physician who made the connection between HPV, oral sex and a new form of throat cancer. She did the right thing: She worked with industry to try and find a cure. She never hid her connection with industry.

That old expression about throwing the baby out with the bathwater keeps popping into our brains ....

Ghostwriting and Full Disclosure: When the Critics Get Caught

A friend and I were discussing the problem of ghostwriting in industry – she was lamenting its demise. My friend, a journalist by profession, didn’t see a conflict of interest problem – she saw a conflict with clarity problem. She had worked for one of the major pharma houses, and one of her jobs was helping a researcher with writing his papers. Scientists generally can’t write, she said.

Anybody who writes for a living who’s seen what a researcher can do to the English language will agree with her. By definition, a ghostwriter is someone who writes for another – he or she doesn’t alter thoughts, tone, meaning, wit. The ghostwriter just makes the prose clear. BioPharma Advisors even uses ghostwriters for some of its own work.


Which brings us to the Wyeth, Prempro, Adriane Fugh-Berman, PLoS Medicine, conflict-of-interest drama. Wyeth (now part of Pfizer) is being sued by women who took the HRT Prempo and contracted breast cancer. The drug maker recently was slammed by Fugh-Berman in PLoS for hiring a communications firm, DesignWrite, to “ghostwrite” articles that touted Prempro’s benefits and smoothed over the risks. These documents – more than ghostwritten -- had been released as part of the court record.

But it was no coincidence that Fugh-Berman wrote the piece, and that PLoS published it. Fugh-Berman, at the time her article was written, was on the payroll of the plaintiff’s law firm. That fact wasn’t disclosed in the article. Another hidden bit of info: PLoS had sued Wyeth for the DesignWrite documents.

Fugh-Berman told Pharmalot that she had never made a secret about her status as an expert witness, and would clarify her position. PLoS editor Ginny Barbour told Pharmalot, “We intervened in the Prempro case solely because of our interest in unmasking this [ghostwriting] practice. We have no professional, financial, legal or other relationship with the plaintiffs or their lawyers in any of the cases that Wyeth is defending, or in any other past or ongoing legal case." Checking Google, very few media outlets covered this part of the story, compared to the splash the PLoS article made. We continue to lament the media’s current lack of parity in covering industry.

The DesignWrite articles ran between 1997 and 2003. Did Wyeth do the right thing? No. Are there reasons that nearly all crimes have a statute of limitations? Yes.

Pharma has said that ghostwriting, as done in the past, will stop. And it should in the context in which it is currently practiced, for at least two reasons: One, it’s not completely transparent. Two, as long as pharma continues to make itself a target, it will be guilty until proven innocent, and its research will continue to be viewed skeptically, and that affects us all.

But please, pharma members – for your researchers who can’t write, hire an editor, and give the guy or gal credit at the article’s end for work done.

The Jupiter Study Dust-Up

When the Jupiter study researchers published their results about Crestor (rosuvastatin) in 2008, this is what they had to say about certain elements regarding the study and its effects on heart disease:

Results showed a true benefit in the rosuvastatin group; there was a 44% lower risk of a first cardiovascular event. Regarding the secondary endpoints -- each component of the combined primary endpoint -- and the subgroup analyses also indicated a substantial risk reduction in cardiovascular events for those patients who were treated with rosuvastatin. As for the absolute risk reduction: because most patients were relatively healthy, it was relatively small.

Why this detail? To talk about the current conflict of interest-related dust-up in the recent Archives of Internal Medicine article.

The Jupiter trial involved 17,800 people and pitted Crestor vs placebo to see if the statin reduced the risk of heart disease in those with high levels of CRP, despite their normal levels of dangerous cholesterol. The FDA, which expanded Crestor’s use this year to people with high levels of CRP and other factors, apparently had no problems with the Jupiter study.

In a FiercePharma story, the Archives authors question the validity of the results from the 2008 study, wondering aloud why the trial was stopped nearly two years into it. The study authors more than suggest there was conflict of interest here because 9 of the 14 Jupiter researchers were financially involved with AstraZeneca, which paid for the Jupiter study. “The possibility that bias entered the trial is particularly concerning because of the strong commercial interest in the study,” the Archives authors write.

"The trial was financially supported by AstraZeneca," says spokesman Chris Sampson in the FiercePharma story, "but AstraZeneca played no role in conducting data analyses and had no access to un-blinded trial data."

It was an independent monitoring board that stopped Jupiter prematurely. The Archives researchers say it was never made clear what the predetermined benefit to one group over the other, was. They also argue that there were too few deaths to be able to say that it was the statin that should have all the scrutiny.

The lead Jupiter researcher told Time that the study population was healthier than other populations, and the study would have had to go on for a long time to “document a difference in heart-related death rates.” The Archives authors “suggest it would have been better to let the trial continue, and find out.”

It strikes us that these authors raise some old issues that were around in 2008. For one thing, the study’s principal author, Paul M. Ridker, is a co-inventor of the patents on the inflammatory markers, but his employer, Brigham and Women’s Hospital, holds the patent. 


It also strikes us that the FDA’s recent action to approve Crestor for otherwise healthy individuals with high CRP levels is not going to hurt other statin manufacturers.

It’s one thing to question the data soon after a study is out; it’s another thing to malign reputations two years after the fact. There’s no call for it. 

Is the Conflict of Interest Tide Turning?

Though we want to imagine physicians as mild-mannered healers, we can’t help but think that some medications would have helped at the recent meeting between folks at the ACCME and the AHA – the one where the ACCME kinda, sorta didn’t reverse its public stance about not letting industry scientists speak at CME-accredited AHA meetings.

Though they won’t admit it.

"We have definitely not reversed course," Murray Kopelow, chief executive of the ACCME, told the Milwaukee Journal Sentinel.

One week industry scientists can’t speak at an accredited event, two weeks later, they can? What happened in between? What should have been happening since the conflict of interest issue first reared its head – a conversation among doctors, on both sides of this debate. Up until now, it’s been the purists’ voices who have dominated the conversation. But after the ACCME announced its decision a few weeks ago, people like Francis Collins and Clyde Yancy objected.

“It is a breathtaking sweep to squash something that is really important to us, the science going on in the private sector,” said Collins, who runs the NIH.

It was Yancy, president of the AHA, who met with Kopelow after the ACCME’s sweeping announcement in mid-June. According to Medical Marketing and Media, Yancy told the ACCME that his group had its own “independent peer-review process and procedure for accepting abstracts.” Apparently, that was good enough for the ACCME. The ACCME now will allow industry scientists to speak at accredited events, as long as the accreditor – the AHA, whoever – has control of the information being discussed.  Yancy brought up another interesting point in the MM and M article – he said industry abstracts presented at meetings are far and few between. “Over the last three years, only about one-half of one percent of abstracts at AHA's annual confabs have been presented by industry scientists. … which is pretty interesting when you consider all the hand-wringing that's taken place as of late.”

Did the ACCME cave to big-name pressure? Maybe, maybe not. What this scene reveals is that those physicians who are not happy about being labeled guilty until proven innocent should say so. It also reveals that when some physicians say, “hey wait a minute, let’s use some common sense,” others might actually agree with them.