Analysis: Senate committee approves drug safety bill, but FDA still runs on Big Pharma money


senateby Mike Adams,

The U.S. Senate Health, Education, Labor and Pensions Committee voted 15-5 to approve a bill that aims to strengthen FDA oversight of drug company advertising and post-approval follow-up studies. The bill was sponsored by Wyoming Republican Sen. Mike Enzi and Massachusetts Democrat Sen. Edward Kennedy. The primary motive for the bill is to give the FDA more power to stop a future Vioxx disaster from being repeated.

The Bush Administration is against the bill and offered sharp objections to the bill's provisions, saying it would slow down drug approvals. Republicans also argued that the banning of drug advertisements on television was "unconstitutional."

The bill aims to accomplish several things:

  1. Allow the FDA to fine drug companies that fail to conduct post-approval safety studies.
  2. Allow the FDA to ban advertising of new drugs for two years after their initial approval.
  3. Allow the FDA to review the safety of newly approved drugs 18 months after approval, and then again at 36 months (three years).
  4. Raise the amount of money paid to the FDA by drug companies for the review and approval of their drugs.

Analysis, commentary and satire by Mike Adams

Okay, let's get to the real story here. The bill has good intentions, but even if it passes, it still leaves the FDA fully in charge of a medical monopoly, paid and influenced by drug companies, and does nothing to outlaw direct-to-consumer drug advertising.

Relevant facts about the FDA and Big Pharma:

  • The FDA is funded in part by the drug companies themselves. Employees who work at the FDA know that drug companies ultimately help fund their paychecks. This creates a dangerous level of collusion between a regulator and the industry it claims to regulate, turning it into a business / customer relationship. This is one reason why the FDA is so eager to please Big Pharma: That's who's paying (part of) the FDA salaries!

  • The United States is the only advanced nation in the world that allows drug companies to advertise directly to the public. It is a dubious practice that has no scientific or medical justification whatsoever. It was legalized in 1998 by the FDA and contributed directly to the Vioxx fiasco as well as the mass medication of American children with mind-altering drugs. Drug advertising should be banned outright. A two-year ban is better than nothing, but an outright ban is the only reasonable resolution of this issue.

  • Just because this new Senate bill would "allow" the FDA to fine drug companies for failing to conduct follow-up safety studies doesn't mean the FDA will actually do so. Much of the language in this bill assumes the FDA actually desires to regulate drug companies and protect the American public. Yet past behavior by the agency has proven the FDA has very little interest in protecting the public. Thus, any "optional" language in the bill may ultimately be useless. A good bill would require the FDA to take specific actions, levy certain fines, and oversee the necessary safety studies.

  • The fact that the Bush Administration is speaking out strongly against this bill is an indication that it's a step in the right direction. Big Pharma has strong financial ties to the Bush Administration and its top officials. Any proposed law that would tighten safety requirements and dampen the advertising and promotion of medications would suppress the profits of drug companies. Hence, Republicans are arguing against the bill in order to protect their campaign supporters -- the drug companies.

  • The Republican argument that banning drug advertising on television would be "unconstitutional" tells us all just how quickly and easily some Republicans have forgotten what the Constitution really says. Freedom of Speech does not protect the right to harm (and ultimately kill) American citizens through a mass campaign of false advertising that promotes deadly products to people who are being tricked into thinking they really need them.

  • Humorous observation: Some lawmakers no doubt think that the Fourth Amendment, which protects us from "unreasonable searches and seizures," must be referring to anti-seizure medications.

Doing a poor job? Just ask for a raise...

Whose idea was it anyway that the FDA is doing such a fine job with regulating the drug companies that it deserves to be paid even MORE money by Big Pharma? It's certainly nothing new in Washington: The worse you do the job, the more money you get.

But the idea is ludicrous. Why should the FDA be even more financially beholden to drug companies than it is already? Shouldn't we be trying to extricate the FDA from drug company influence and let the agency stand on its own, funded with public money, and operating on some sort of sworn oath to protect the consumer?

If things were set right, the FDA should be Big Pharma's worst enemy. The FDA should be hammering drug companies with stringent safety requirements, skeptical thinking about drug benefits claims and huge fines for those companies that get caught conducting fraudulent science or burying the results of drug studies they don't want the public to see. To be really effective, the FDA needs:

  1. Complete independence from Big Pharma. This means the agency must run on public funds only and receive no money from the industry it claims to regulate.
  2. A new set of scary teeth. The FDA needs to be able to take strong action against drug companies by levying fines, banning dangerous drug products and even confiscating pharmaceutical inventory. Don't you find it curious that the FDA has raided lots of vitamin companies and confiscated countless truckloads of nutritional products, but has never (to my knowledge) conducted an armed raid on a major pharmaceutical company and confiscated the brand-name prescription drugs that are actually killing people?

The truth is, the FDA treats Big Pharma with kid gloves. It even "negotiates" with drug companies to decide on how, and when, and at what size safety warning labels should be printed. This is absurd, and it shows who's really in charge when it comes to drug safety (the drug companies themselves!).

Then again, all this assumes the FDA actually wants to protect the public, and I don't believe the agency wants to. I think the FDA just pretends to protect the public in order to meet the minimum regulatory requirements that prevent a real Congressional inquiry. The FDA seems to be merely going through the motions of regulating drug companies, without actually pursuing the task with any genuine sense of purpose.

It's like an empty shell of a government regulator. It might as well be renamed to, "The Big Pharma Administration." Because that's where much of the money comes from, and that's where the interests of the top decision makers seem to be focused.

Kudos to Wyoming Sen. Mike Enzi for having the courage to co-sponsor this bill. I've personally met Sen. Enzi, and he's among the most progressive, energetic Republicans you'll find in the Senate. It must have taken really political courage for him to put his name on such a bill, knowing that the leaders of his own party would line up so strongly against him on this issue.

For Senator Kennedy, the decision was probably a little easier. Democrats are increasingly aligned against Big Pharma, and there's broad support in the Democratic party for some sort of major health care reform that would likely involve major FDA reforms at the same time.

But they both deserve credit for trying to move this bill forward. It's not the bill that I want, but it's a bill that's better than what we have right now. It's a step in the right direction, and sometimes that's all you can realistically hope for in Washington.

In case anybody out there is interested in REAL reform that would rein in the drug companies and protect consumers, here are the top five things that need to be done:

The top five reforms we really need

  1. Ban all direct-to-consumer drug advertising. It never should have been legalized in the first place. There is no logical medical argument that justifies the practice of promoting prescription drugs directly to consumers.
  2. Fund the FDA entirely with public money. It's crucial to disconnect the FDA from the purse strings of Big Pharma. FDA funding should come from those it answers to: the taxpayers.
  3. Make the reporting of drug side effects mandatory. When doctors or drug companies learn about a patient experiencing a side effect, it should be mandatory to report that side effect to the FDA.
  4. Require the open publication of all drug studies. Currently, drug companies hide the studies they don't want you to see, and they only publicize the (fraudulent) studies that produce the results they like. We need to change this and shine some light on the results of ALL clinical trials to let doctors, patients and everyone else examine the science for themselves. (The pharmaceutical industry argues venomously against this. They think drug studies should be kept secret.)
  5. End conflicts of interest at the FDA. Require, by law, that anyone who works for the FDA, advises the FDA or participates in FDA decision processes has no financial ties whatsoever to drug companies or medical device makers. No consulting fees, bribes, stock options or incentives. The people who make decisions about the safety of the drugs approved in this country should have no financial ties to the companies impacted by their decisions. It's common sense.
Pretty simple, huh? Five reforms that would restore some honesty and integrity to the FDA.

Protecting consumers from dangerous drugs is really not that difficult. The necessary reforms are easy to see. It's just that drug companies have their financial tentacles wrapped around so many legislators that real reforms are politically strangled to death before they have a chance to get voted on ("killed in committee"). With some notable exceptions, Congress has been bought out by Big Pharma. Wholesale, meaningful reform is currently not even being debated. The only things being talked about are changes so tiny that it's like pointing a rowboat two degrees to the left as it floats aimlessly in a sea of corruption.

Is it a step in the right direction? Sure it is.

Is it a real solution to FDA corruption and Big Pharma influence over conventional medicine? Not even close.