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The FDA's Walk of Shame
A test case for the new government will be how it deals with the pharmaceutical industry, which rivals the gun manufacturers and tobacco companies for the position of most amoral industry in America.
Democrats have long been promising to stand up to Big Pharma on issues like Medicare drug pricing and importing drugs from Canada, but they've accomplished little since they won Congressional majorities in 2006. If they truly want to reign in the drugmakers now that they have the clout, they'll need to not only move forward on these hot-button issues, but also completely overhaul the Food and Drug Administration, which stands as one of the most corrupt and compromised bodies in the federal government today.
Last week offered a glimmer of hope, with a bipartisan bill aimed at one of the many scurrilous practices employed by drug companies to win swift approval for their products and push them on the public. Called the Physician Payments Sunshine Act of 2009, the legislation was introduced last Thursday by Senators Herb Kohl (D-WI), Chair of the Senate Special Committee on the Aging, and Charles Grassley (R-IA), in the past a rare Republican voice opposing some of Big Pharma's outrages. They are calling for establishment of "a nationwide standard requiring drug, device and biologic makers to report payments to doctors to the Department of Health and Human Services and for those payments to be posted online in a user friendly way for public consumption."
Let's be clear: The proposed legislation doesn't say that doctors can't receive money (or expensive dinners, or luxury junkets) while they are testing or endorsing new drugs; it merely says the payments have to be made public. Even this, however, has apparently proven too much for the Food and Drug Administration: A report released earlier this month found that the FDA had been sorely lax in demanding full disclosure of these relationships. As reported by Bloomberg News:
Drug regulators haven't done enough to force disclosure of financial conflicts of interest among the researchers who conduct clinical trials of medications and medical devices, according to a U.S. government investigation. A total of 42 percent of marketing applications approved by the U.S. Food and Drug Administration were missing financial information that was supposed to be submitted by drug and device makers, according to a report today by the Health and Human Services Department's inspector general. The FDA didn't act against the companies, the report said.
Financial connections between companies that make drugs and devices and the doctors and other researchers who test them on humans may compromise the safety of patients in studies and the integrity of the results, according to the inspector general's report. Lawmakers, led by Senator Charles Grassley, a Republican from Iowa, have raised concern that financial conflicts of interest among doctors and manufacturers may influence prescribing decisions.
The FDA has fallen a long way since 1962, when legendary Senator Estes Kefauver championed its expansion, insisting that it was the federal government's responsibility to protect the public by ensuring that prescription drugs were both safe and efficacious. The FDA has for decades been playing footsy with the drug industry, and it reached new lows under George W. Bush, as fundamentalist Christianity became yet another force undermining the agency's work. Bush's appointments to the FDA leadership included a veterinarian who presided over the Vioxx scandal and stalled the Plan B pill, and a faith-based gynecologist who refused to prescribe contraceptives to married women and advised prayer as a treatment for many female ailments.
In a 2006 survey of FDA employees, more than 40 percent said they knew of cases in which political appointees had interfered with agency decisions. At that time, more than 100 whistleblower cases were also pending at the agency. Some things will now surely change at the FDA--but how much, and how soon?
Obama has yet to announce his nominee for FDA commissioner, but HHS Secretary Tom Daschle talked about the agency at confirmation hearings earlier this month, promising "to ensure that trust in FDA is restored as the leading science-based regulatory agency in the world. …I will send a clear message from the top that the President and I expect key decisions at the FDA to be made on the basis of science--period."
It's true that we're unlikely to see prayer meetings in Tom Daschle's HHS. But independence from Big Pharma is another story. Since leaving Congress, Daschle has been working as an "adviser" to health care industry clients, including at the law and lobbying firm Alston & Bird. As the New York Times reported at the time his nomination:
Although not a registered lobbyist, Mr. Daschle, a South Dakota Democrat who was party leader in the Senate, provides strategic advice to the firm's clients about how to influence government policy or actions….As examples of the firm's achievements the Web site lists matters involving Medicare and Medicaid reimbursements, approvals of federally regulated drugs and medical products, fraud investigations, medical waste disposal, privacy and other compliance issues.
On the day Tom Daschle was nominated, the Washington Post's "The Ticker" blog reported:
According to Wall Street, Tom Daschle is a good choice to be the new secretary of the Department of Health and Human Services. Shares of the big drugmakers--Pfizer, Eli LIlly, Merck, GlaxoSmithKline and AstraZeneca--are all trading up from their opening this morning.
If you read the fine print in the drug adds it seems to me that the side effects are sometimes worse than the disease.
Why cant the drug companies be forced to not sell their product until the side effects are under control.
Many of us have been fighting against the FDA's uncomfortably close connection to big Pharma. They have followed big Pharma's instructions on homeopathic medicines that often work better than what they put out without any of the abnormal side-effects such as colloidal silver.
Obama's going to have to surgically separate the FDA from big Pharma so that none of the doctors -- real or faith-based -- will be beholden to anyone other than the People.
Oh, how I hope AND pray that the FDA will be properly regulated under the Obama presidency. I am one who was very greatly harmed by the FDA's approval of Merck's poisonous vIOXX.
Big Pharma not only sells snake oil but has corrupted the FDA as well as the Congress. It is so deeply entrenched and has so much money to throw around I suspect that little if anything will change with regard to activities at the FDA. What will occur is entirely cosmetic and will not benefit the average citizen in any significant manner. The prices of our brand name drugs are outrageous compared to those in Europe. Big Pharma tells us research is expensive. In fact, every thing in Big Pharma is driven by the marketing departments. The budget for marketing regularly exceeds that for research. Big Pharma is the enemy. It's a cancer on the backs of all americans and should be treated as such.
Kevin, I hope you meant that Obama's administration will REIN in Big Pharm (to control, using reins, as with a horse) as opposed to REIGN in (to rule over) - the latter suggests anointing the pharmaceutical industry as royalty.
The US consumer pays more for their drugs because we have no central healthcare system to negotiate a reasonable price, like other countries, and the manufacturers raise prices here to make up for the perceived shortfall. Also, direct marketing to consumers, which had previously been banned, has probably more than doubled advertising and marketing costs, which are included in the price of every single little blue pill. What irks me the most is that so many new and promising drugs are on the market, but the average American can't afford them without extremely good health insurance. I have rheumatoid arthritis, and the biologic drug I inject once a week to slow the progress of the disease costs close to $4500 for a 3 month supply. I could never afford that without my employer's health plan. If I were without insurance I would just have to suffer, and become disabled that much sooner.
Prayer, eh? No wonder they didn't want to back up my non-Christian selfs transfer from using Oxycontin to Medical Marijuana for Pain; it must have been clear to them that Jesus wanted them to hurt me, for refusing to be saved!
No wonder I had people encouraging me to 'Have children anyway' (though my Neuropathy is Autosomal, and 9 out of 10 of them would have it), by saying that they would "Pray for them to be well; or don't you believe in the power of prayer, like we do?"
At least we did have one thing in common; whether it be Faith Healing, or switching over to The Good Herb, the Drug Companies were losing out in either case!
Now that's one example that I'd like to see the Obamaficator emulate; howza 'bout y'all?
"If you read the fine print in the drug adds it seems to me that the side effects are sometimes worse than the disease.
Why cant the drug companies be forced to not sell their product until the side effects are under control."
It is true that we hear some stunning reports in the media about some fatal side effects of drugs that are suppossed to save lives. However, this comment is intended to focus on what you said about the fine print about side effects of the drugs. I work as an Administrative Assistant in a Critical Care Research in New England. One of the first things I learned when I started in this job was why it is important to carefully consider all those bizarre and horrible sounding side effects that are relegated to the fine print. During the course of conducting an investigational drug trial, all untoward events which a patient experiences while receiving the investigational drug or up to a 6 month time frame after receiving the drug are reported to the Pharma companies as well as to Institutional Review Boards (ethics oversight and patient protection) and eventually to the FDA. The events can be anything ranging from headache to death. During the course of the investigation, the attending research Doctor must determine, based on their expertise the extent of the possible relation of the event to the study drug. Even those events that are determined by trained professionals to be not related or not likely to be related to the drug end up being reported to the FDA and that is how they end up in the fine print as possible side effects. So while it is a very good idea, to pay attention to the side effects, it is also important to keep in mind that some of those reported side effects only occurred in a very small portion of the study population and may nothave even been definitively linked to the drug.
IF the FDA was a building everyone would see clearly that the rot runs so deep that the only solution would be to tear it down and build afresh.
The pharmas have spent too much time above the law, it's time to make them accountable.
"...it is also important to keep in mind that some of those reported side effects only occurred in a very small portion of the study population and may nothave even been definitively linked to the drug."
That may be true BUT the pharmaceutical industry does everything it can to hide or at a minimum play down the problems of side effects and drug interactions. For example, right now the drug companies spin research to encourage doctors to prescribe statins for as many people as possible; side effects are minimized. Statins, if they in fact do anyone any good--something which is debatable although you'd never know it from all the drug industry propaganda masquerading as scientific research--have been shown to be useless and dangerous for women and for anyone, male or female, over 70. Nevertheless, many doctors are so poorly informed and/or so under the sway of what they hear from pharmaceutical reps that they prescribe statins for these people anyway. There are people out there who have had their lives destroyed because essentially the medical community is not paying attention to what their patients are saying but rather to the drug companies whose primary interest, unfortunately, has more to do with making money than with helping people. The recent JUPITER study, as a result of which doctors are being encouraged to put an additional 7 to 11 million people on Crestor, a statin, received vast amounts of publicity about the wonders of preventive treatment with that drug. The flaws with the study have been pointed out by a number of people but that information is like a whisper compared to the hosannas ringing out for Crestor. And it's not only statins. How many women are taking Fosomax and have no idea of the very real dangers that exist with this drug?
It is all too true that the drug companies desperately need to be reined in.
I wonder if any of the people of FDA or Big Pharma take any of the drugs that they push.They probably read the really fine print.
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