Drug Industry Lobbyists Kept Clinical Trial Results Secret

The Sunlight Foundation reports on how lobbyists for the pharmaceutical and medical device industries impacted one woman's health problems.

Suffering from debilitating migraines, Bray Patrick-Lake volunteered for a Food and Drug Administration-regulated clinical trial. But three months after joining the study, it was abruptly halted. Device manufacturer St. Jude Medical Inc. said the study didn't have enough volunteers.

Patrick-Lake was unable to find out the results of the trial, which required her to undergo a surgical procedure to have a device implanted in her heart. It helped her migraines, but it caused some other problems.

She wonders if St. Jude knows of problems with the device that the company is not revealing. But she has no way of finding out. "I think I have the right to know that," she says. It upset her to find that because the trial was cancelled, St. Jude Medical was not required to release trial results to her or to anybody else. "To provide for my own best care in the future, I should know everything about this device and be able to share that with my doctor.

Health industry lobbyists pressed lawmakers to change the wording in a bill that would have required public access to results of clinical trials that don't result in an approved drug or device, reports the Sunlight Foundation.

In 2007, the pharmaceutical and device industries funneled $3.4 million to members of the House Energy and Commerce Committee and the Senate Health Education and Labor Committees as they debated legislation on transparency in clinical trials.

Time reported earlier this month that the pharmaceutical industry has spent more than any other segment of the medical industry lobbying for health care legislation in 2009. Drug companies and their trade organizations spent more than $110 million, or $609,000 a day, to craft health care policy to their liking.

The drug industry's Washington lobbyists outnumber members of Congress by 2.3 to one, according to Time.

Comments

[goodnews7]

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[stargazer13]

is it not amazing at all the money our elected officials receive

I my self call them bribes !!!!

I can not stand it any more they are all thieves trying to steal us blind !!

[Whatevah]

But . . . if they didn't have enough volunteers, they had no results to share.

I don't understand how someone can ask for data that doesn't exist.

[Am-I-Dreaming]

Let's apply just a smidge of critical thinking here, whatevah. Of course they had enough volunteers. They started the study, didn't they? Ask yourself the obvious question: If they didn't have enough volunteers, why did they implant the device into her and begin the study? For fun?

Clinical trials aren't initiated on a "gee let's hope enough people show up" basis. They're not Mickey and Judy backyard musicals. There's paperwork, etc. to be done and, oh yes, wads of money to be spent. There is always attrition, so studies frequently start with more subjects than are needed. And let's be realistic: No company is going to throw money at a study if they don't think they will get the results they want. Duh.

Okay, next point: Of course they had results, otherwise they wouldn't have stopped the study. Otherwise, why would they have done that? Because the researchers had something better to do? Think about it. They realized very early on that what they wouldn't end up with were results that showed benefits (to the company) that outweighed the risks (to the humans). Given what other studies have done to the human subjects involved, the problems in this study had to be pretty significant. What I'd like to know is whether they ever removed the mystery device from this woman's body.

[Whatevah]

This entire argument is based on the completely unfounded idea that the study organizers lied when they said they didn't have enough volunteers. You have no evidence at all that such a thing happened.

In addition, your understanding of clinical trials is wrong. Clinicians do indeed begin their research before they know if they will have enough volunteers. This is especially true of very large studies, which require enrolling volunteers over a number of years. They'd never got started if they waited until they had all the subjects they need.

Another misunderstanding is your idea that studies are not cancelled for lack of volunteers. Wrong. Happens all the time.

Finally, you also misunderstand the way that findings are generated. You have to collect they data, then analyze it. If they didn't have enough data, it is impossible to generate statistically significant findings. The lady in question wanted to know about possible side effects and the effectiveness of the therapy. Without enough data, there is no way to pinpoint either of these things.

I wish America's public schools did a better job teaching math.

[ssaz]

And exactly why does the GOP continue to defend insurance, medical, and pharma industries? Greed and corruption; no other reason. I would venture a guess that 85+% of our politicians are criminals.

[Sundialsvc4]

The Constitution of the United States, Article 2 Section 4, does not call this $609,000-a-day "spending."

Nor "campaign contribution."

Nor "lobbying."

The Constitution declares (as the United States Code also declares...) that this is "bribery," and stipulates that "any civil officer SHALL BE removed from office" (and criminally prosecuted) for it.

If we do not enforce even "the Supreme Law of our Land," then we have no law at all. No protection of any kind. And, that is not what We the People of the United States gave "the consent of the governed" to receive.

[ZellaBee]

i think anyone who volunteers for placebo studies or any other kind is cr@zy! Trust drugmakers? Not me.

[Elaine2]

Merck pharmaceuticals and the FDA allowed the marketing of VIOXX -- an arthritic drug that caused 100,000 heart attacks and 50,000 deaths. Despite the FDA's own scientist's warning about the dangers of Vioxx, the FDA allowed its marketing since there is a revolving door between the FDA and RX co.s. A powerful employee of a pharmaceutical co. will leave the company to work at the FDA, writing the necessary legislation to have a new drug, such as VIOXX, marketed. This employee and many people who serve on the FDA's Advisory Committee will own stocks in this new drug.

RE: VIOXX - Merck paid billions in a class-action suit, but it is still a powerful RX co. The FDA's scientist was interviewed on "60 Minutes" and described the threatening calls he received from FDA employees, since he was not going along with the "party line."

The passage of health care reform is only a beginning. Mainstream medicine and the establishments involved, must be overhauled. OZONE destroys cancer, but is deemed illegal by the FDA because it is a natural substance which cannot be marketed. Download free Updates from "Innocent Casualties: The FDA's War Against Humanity" to know the truth about the FDA and the orthodox medical establishment.

[vippy]

I hate all pills and capsules, etc. but VIOXX was a good tablet. One has to wonder what people
took besides that which caused heart attacks, etc. Sometimes people, on their own, take this and that drug and then those two don't match and you have a problem. So many people took this product and had no problem at all. But then all drugs have side effects and we know the FDA
does conceal those! The FDA is not our friend.

[Democratuser]

as stated by http://financeopinionss.blogspot.com it is time to create economic growth that we can all benefit from; not the top 1% of earners.

An equitable economy is a better one.

[Deninor]

Of course,Jjarrett thinks Fox News is biased. It keeps picking off the Communists, Marxist and Maoists on our socialist team. If they were true members of the main stream media they would be with us all the way on our march to socialism and the introductrion of poverty and fairness to all Americans. Deninor

[instarx]

You're so dim you can't even post to the correct article.

[vippy]

LOL, with names like Marxists, Communists, and Maoists, people have to know we are in the wrong century!!!!