Top 10 False Claims Act

Top 10 False Claim Acts

Under the False Claims Act, 31 U.S.C. §§ 3729-3733, those who knowingly submit, or cause another person or entity to submit, false claims for payment of government funds are liable for three times the government’s damages plus civil penalties of $5,500 to $11,000 per false claim.

This act allows citizens with proof of fraud having been committed against the government to sue, on behalf of the government. These whistleblowers are compensated between 15 to 25% of the funds recovered by the government.

I thought that it would be interesting to see the amounts that have been paid back to the government due to the False Claims Act. Here is a list of the top 10 false claims:

Company	Amount	Date
Pfizer	$1,000,000,000	September 2009
Tenet	90,00,00,000	July 2006
HCA	73,14,00,000	December 2000
Merck	$650000000	January 2008
HCA	$631000000	June 2003
Serono Group	$567000000	October 2005
TAP Pharmaceuticals Products Inc	$559483560	October 2001
New York State and New York City	$540000000	July 2009
Schering Plough	$435000000	August 2008
Eli Lilly	$438000000	January 2009

I just thought it would be interesting for us to know about to what extent the government recovers money lost due to health care fraud.

The top 100 false claim act cases can be viewed at : http://www.taf.org/top100fca.htm

Wyeth Vs. Levine

For those of you who haven’t read about the Wyeth v Levine case, here are two links.
Wyeth Loses Preemption Battle and The Facts—Wyeth Vs. Levine
There are a lot of issues to be addressed in this case, I do realize that. My main issue is with the fact that Wyeth wanted to change the labeling on Phenergan regarding intra-arterial administration of the drug, but the FDA specifically asked them to retain the language on the label. In the end, Wyeth was sued by Diana Levine for not including appropriate information on intra-arterial administration of Phenergan. For once, I believe that the drug company isn’t at fault. The FDA, the body that regulates drugs in the United States, asked Wyeth not to make changes in their label. And they get sued for not making changes!
Not being a lawyer, I’m sure I don’t understand the case as well as a lawyer would, but I am truly bewildered by the thought that the FDA would ask a drug company to not include a warning when that drug could be potentially harmful.

FDA and the Declaration of Helsinki

The Declaration of Helsinki renders protection to human subjects in clinical trials. It gives a set of ethical guidelines to follow while conducting clinical trials involving human subjects.

The Declaration isn’t so much a law as it is a set of guidelines. But, in the global scenario countries do tend to stick to these guidelines and not violate them.

But not the FDA.

In April of 2009, the FDA issued a statement saying American trials conducted outside the United states would no longer be required to adhere to the Declaration of Helsinki. This also means that pharmaceutical companies can use placebo instead of the current standard of medical care as the control.

Why would the FDA do this? The United States conducts clinical trials in so many countries including developing countries such as Brazil, India, China, and so many African countries.

The people in these countries may not necessarily be educated, literate, and many may not be able to understand the details of the informed consent form. But, they would still agree to participate in the trial because of the compensation they receive, however menial it is.

These underprivileged people are easy targets for unethical practices of the pharmaceutical companies.

Also, using a placebo instead of a comparable treatment may lower costs of the trial, but the trial is not being conducted with scientific integrity. Results of these trials wouldn't give us clear idea of the effects of the drug being tested, because the drug is being tested against a placebo (=nothing)!

Shouldn’t the FDA ensure that these people are protected in the same way that Americans participating in trials are? Aren’t all people equal?

Look what happened with Pfizer in Nigeria. Does the FDA want the blood of innocent people on it’s hands?

Cancer drugs, patients, and the FDA: Where do we go now?

To

I read an interesting article in the New York Times a few days ago (Where Cancer Progress Is Rare, One Man Says No. September 15th, 2009), which talks about the possibility that the FDA is over-regulating cancer drugs.
Reading the article got me thinking: When dealing with a disease like cancer, which in many cases is fatal, should the FDA be more lenient while approving drugs to treat cancer? The rationale behind this is that, people who have cancer already suffer from the terrible manifestations of the disease, so what’s the harm in giving them drugs which may have terrible side-effects and which may or may not cure their disease? To these patients or to their families, they have nothing much to lose.
My take on this:
The FDA is one of the most reputed regulatory agencies in the world. It has certain standards that it adheres to, no matter what. If the FDA started approving drugs, just because these drugs treat terminally ill people who may not live in any case, the agency would lose its credibility. Why should the FDA single out only cancer patients? Can’t an extremely obese people ask the FDA to approve drugs that help you slim down, even if these drugs may wreck havoc on the liver and kidneys? What about Alzheimer’s patients? They are generally headed down a dead end street. My paternal grandfather has a condition very similar to Alzheimer’s. I would love for regulatory agencies to say: Well, these people have nothing to lose. Let’s just approve the drug and hope for the best. No, it doesn’t really work that way.
The other drawback is that, if the FDA were to approve these drugs and if something went wrong, as with Rofecoxib, Nimesulide, or Thalidomide, nobody would remember that the FDA approved these drugs(I’m talking about hypothetical drugs which could be approved in the future because of pressure from patient advocates) because of public pressure. The outcome of this would be lawsuits, lawsuits, and more lawsuits.
The FDA may not always make the best of decisions but on this subject I stand by them.

Ghostwriting and Ethics

Many industries, including biography publishing and even rap, employ ghostwriters without significant concerns. However, the use of ghostwriters in medical writing has raised ethical concerns. The medical industry uses ghostwriters to edit, revise, and polish the writing of physicians and scientists whose writing may not adequate convey ideas clearly.

First, one must ask how pervasive the practice is in the pharmaceutical industry. In an August 5, 2009 article in the New York Times, Joseph Ross, MD said referring to ghostwriting: "It's almost like steroids and baseball. You don't know who was using and who wasn't; you don't know which articles are tainted and which aren't".

Does ghostwriting determine scientific integrity? The most vocal critics say that research findings can be skewed by contributions from writers who are employed by pharmaceutical companies and don't disclose these relationships. A September 18, 2009 NYT article explains that the editors of Blood determined that a pharma employee had contributed significant portions to an article published under the name of prominent researcher. The editors believe that the ghostwriter should have been listed an author, and not merely listed in the acknowledgments as was the case. In another case, Wyeth employed ghostwriters to down play the risk of hormonal therapy for menopausal women. Articles were published in 18 well-respected medical journals between 1998 and 2005. Later research uncovered the truth: the therapy caused an increased risk of breast cancer, heart disease, and stroke.

Who loses in these scenarios? Wyeth's revenue rose to almost $2 billion from sales of Premarin and Prempro. It is not clear if Wyeth's reputation suffered as a result. Women taking these medications were certainly losers. Experts also agree that medical research as a whole suffers. Jeffrey Francer of the Pharmaceutical Research and Manufacturers notes that ghostwriting transgressions and the resulting restrictions put in place by journal editors to identify ghostwriters could "chill research and chill support for research". So we all lose.

What solutions exist? Journal editors and legislators are pushing for requirements that require lead authors disclose all other contributors or risk being barred from writing for academic journals for an indefinite time period. Other journals no longer publish "opinion" or editorial articles from writers who have ties to pharmaceutical companies.

Ghostwriting in the pharmaceutical industry is pervasive and fulfills a necessary role. However, relationships to drug manufacturers should be disclosed and should not stop negative information about drug side effects from being published.

Outsourcing clinical trials : A big pain, but is there much gain?

Clinical trials are now moving to countries all over the world: China, Kenya, India, Tanzania, Nigeria, and everywhere else!

From the economical standpoint, conducting a clinical trial in one of these developing countries is relatively cheaper than conducting them in developed countries in North America, Europe, or Australia.

But the more compelling reason to outsource clinical trials is to test drugs on a diaspora of people, people with different genetic make-up, as well as to test drugs for diseases such as malaria, HIV, meningitis etc, which are more common to these developing nations.

But outsourcing clinical trials is not as simple as packing up your bags, getting onto a plane, and jetting off to a foreign land.

Clinical trials outsourced to developing countries are watched by IRB’s and regulatory agencies with the same level of scrutiny (if not a higher level) as those conducted in developed countries. In fact, various reports say that it’s tougher conducting trials in developing countries because of the ethical and legal guidelines that have to be followed.

I believe that informed consent in outsourced clinical trials would be a difficult task because the researchers would have to factor in cultural characteristics while preparing informed consent forms and while talking to clinical trial subjects. It also would be a problem when dealing with an illiterate or uneducated population, in which case simple language and efficient translation wouldn't be of much use.

The Declaration of Helsinki renders protection to human subjects in research who are underprivileged. Thus, IRBs and regulatory agencies have to ensure that these subjects are not being mistreated. The IRB from each participating institution/company needs to approve the clinical trial protocol. So very often you're stuck waiting for IRB approval from a dozen different institutions! How does this make a clinical trial more ethical or even ethical, for that matter???

I understand the need for an ethical and protocol review by an IRB. But, why can't just one IRB do the job?

Just a suggestion, but maybe they could have one IRB on behalf of the participating institutions and one local IRB. It would make things easier, speed up the trial, and save a lot of money.

Ok, so outsourcing clinical trials isn't the easiest task in the world. But what happens after you get IRB approval? After you begin the trial?

I'm sure that many of these trials are successful and offer the people of these countries a chance to receive possible life-saving drugs. But are these trials conducted ethically? A 100% ethically? Having lived in both India and Africa I can't help but imagine a lot of money hungry officials looking out for a quick buck in exchange for speeding up the process locally. I somehow can't believe it's all smooth sailing after IRB approval.

What do you all think?