December 31, 2003

Naw, Bush had Nothing to Do With Libya Coming Clean....

I mentioned this elsewhere about ten days ago, but couldn't provide a reference for what should be obvious reasons--the news was not yet "public" and the person who provided it sure wasn't going to tag their name on it. So when folks wrote and called me a liar, I had to bite my tongue and take my lumps, not being Matt Drudge or anyone resembling him.

The accusation was that Libya's decision to come clean on their WMD programs was NOT a response to the Iraq invasion, or to any U.S. enforcement of WMD restrictions. When I said otherwise and cited this incident, I was castigated for making things up. Some folks just can't concede that the Bush strategy in the Middle East has had some positive results. So now that it's public knowledge, here's what really provided the final impetus for Qadaffi's sudden change of heart, and brought him to the table.

U.S. Blocked Centrifuge Parts for Libya

December 30, 2003

Politics, Autism, and Science

Can't I find anything to write about other than health care and drug companies? Well, usually yes, but it's been a landmark year for blatant greed and naked political corruption by the drug companies, so fresh insults to my intelligence have inspired me lately.

The latest insult comes on the Wall Street Journal editorial page of December 29, and it's called The Politics of Autism--Lawsuits and emotion vs. science and childhood vaccines, in which the WSJ castigates three Moderate Senators for holding up a "reform" bill that would cut the pins out from under the Greedy Trial Lawyers bedeviling those pristine drug companies, and threatening our vaccine supply. It's a well-written editorial, and would normally have had me cheering for anyone who could muzzle them thar lawyers, except....

Except that I've followed the issue for years, and what is noticeably lacking is some background on the controversy. Details like the situation that led to the flap in the first place. Details such as the thorough discrediting of the (drug company sponsored) studies the Journal cites as "definitive science" of no vaccine/autism link. Details like the REAL reason Frist's VICP "reform" bill hasn't made it out of the joint House/Senate committee. Details like Senator Frist's incestuous relationship with the drug companies, and his self-interest as a major stakeholder in the Hospital Corporation Of America (HCA).

The Journal (and the Frist crowd, and the Bush administration) would have you believe that the vaccine/autism link has been totally disproved. The autism advocates would have you believe there is no possible doubt of a connection. The scientists and statisticians and analysts among us who've reviewed the data know that it may take decades to prove either way (e.g., the causative mechanism for thalidomide injuries was not found until the '90's!) and that the evidence of a link is ambiguous but by no means insubstantial. So, as Paul Harvey says, "And now, the rest of the story."

The real issue in this case is NOT whether infant vaccines and components therein can be linked to the epidemic of Autistic Spectrum Disorder. Despite what you may hear from either side, the definitive science is still not there either way. The real issue is that the drug companies want a blanket immunity from ALL vaccine liability, regardless of what science may show now or in the future, and their Congressional lapdogs are quite willing to provide it. On the other side, Congressional supporters of the tort bar want to open the cash vaults of the drug companies. In the middle, thoughtful and sober moderates want to address the actual problem with a real solution, and are keeping both the drug reps and the lawyer-lovers at arm's length and stalling bad bills. And the basic problem that needs fixing is a thoroughly dysfunctional Vaccine Injury Compensation Program (VICP) desperately in need of reform and repair.

VICP was designed to compensate those injured by acute reactions to vaccinations. It has an incredibly short filing statute, 36 months maximum. It has absolutely NO provisions or mechanisms for dealing with any chronic or late-appearing vaccine injuries. None. And the average age of diagnosis for ASD aka "autism" is about four years. So parents believing their child's autism might be related to vaccines discovered that, regardless of the science, regardless of any American conception of justice, they were barred by federal law from making any legal claims anywhere except the VICP, but that they couldn't make any claims with the VICP because the filing statute ran out before their child was even diagnosed.

So the parents went searching for lawyers who could find loopholes, and they found them, and the lawyers found loopholes and proceeded to sue the bejeezus out of the drug companies. The drug companies, looking at a plaintiff's class of tens of thousands of autistic children, panicked and went running to their friends in the federal government. Specifically, to the Bush administration and Senator Frist. And the administration saw those tens of thousands of claims and realized that if they made it into the system and there was anything at all to back them up, either the drug companies or the government would have a tab of many, many billions to pay out, and that public faith in the vaccination programs would be severely shaken. So, lo and behold, in the middle of the night several clauses were anonymously inserted in the Homeland Security bill, clauses that would have forced all current and future vaccine-related claims of any kind into the VICP, where they were utterly assured of being rejected due to the time limits. A hue and cry arose from the lawyers and the parents, and the clauses were stripped out when Congress reconvened in January.

Then VICP reform bills were passed by both the House (R-Burton, IN) and Senate (R-Frist, TN) and went into joint committee in April, where they deadlocked. Burton's bill would reform the VICP to address chronic injuries, and provide for future claims on newly discovered causation. If conclusive evidence was found in the future that vaccines were implicated in autism, then claims could be made on behalf of those tens of thousands of kids without the filing statute being applied to exclude them. Frist's bill superficially looks much the same, but would only allow claims excluded in the last six years to be brought forward, and would not reform the VICP to address chronic injuries. As thimerosal was pulled from infant vaccines in 1999, the longer the bill takes to pass, the more autistic kids who received thimerosal-containing vaccines would be excluded from claims by time limits, no matter what science the future may bring. (The bulk of thimerosal claims would by definition be from children born between 1985 and 1999.) Thus, if evidence of a definitive autism/vaccine link was ever uncovered, the bulk of those injured would once again have been excluded from ever, in any venue, seeking damages or compensation.

You can guess which part of the two bills has resulted in the lack of compromise, and intense and massive lobbying by the pharmaceutical industry to pass the Frist version of the "reform" bill. Yep, the part that would allow claims based on new evidence to be allowed without applying the filing limit.

The administration, the Wall Street Journal, and Frist's favorite contributors want the Frist bill. The trial lawyers and their Congresscritters, and the "true believer" parents of autistic children want litigative blood, and an open shot at the deep pockets of the drug companies. The there's those of us in the middle who still believe that justice is desirable in our society and would like to see Burton's bill pass, leaving the VICP open to retroactive claims if and when the science is there to support them. My hat is off to Snowe, Collins, and Chafee for holding their ground and keeping the Frist bill bottled up despite intense pressure.

December 24, 2003

I Just Can't Leave 'em ALone!

I've written extensively about the Medicare Bill both here and elsewhere. Now comes the confirmation that of all the things the bill is intended to do, actually lowering drug prices is NOT one of them.

To be sure, much of the stated intention of the bill is to lower drug costs to the elderly with huge drug bills. And to some extent it actually does that, by shifting the cost burden to the taxpayers. But it doesn't do a single thing to control the extortionate price of drugs that led to millions of Americans buying their drugs from Canada and other countries. Quite the opposite--by tapping into the Treasury, the bill gives pharmaceutical companies a blank check to continue making huge profits stiffing U.S. consumers with much higher prices than they sell those same drugs for elsewhere. This is why the drug companies were all in favor of the bill, and massively lobbied for its passage.

It's also why the bill specifically prohibited states and cities from negotiating price agreements on their own to reduce the cost burdens they face. Predictably, those same cities and states, faced with sharply rising drug costs both under Medicaid programs and their own self-funded health plans and with the ban on price negotiations that by itself constitutes a huge unfunded federal mandate to pay extortion to the drug companies, are exploring and establishing their own deals with Canadian drug suppliers, which has the FDA frantic. The FDA is going to great lengths to discourage the practice, which is illegal under federal law. To do so, they not only are loudly threatening legal action against the cities and states, but also trotting out the old "foreign drugs are not safe" argument.

Canadian drugs are susbstantially cheaper for two major reasons. The first is that under the Canadian health care system, the individual provinces are allowed to negotiate prices with the drug companies. The second is that Canadians aren't stiffed the same "premium" for drug development costs that U.S. consumers are. So Canadian drugs are cheaper because they can negotiate prices, and because American consumers already subsidizes the lower price of foreign drugs by soaking up those development costs themselves.

Remember, these are the same drugs, produced by the same companies, that Americans get. The drug companies tried the "foreign drugs aren't safe" argument briefly during the debate on the Medicare Bill, but quietly dropped it when people started asking why drug companies were manufacturing and selling unsafe drugs to Canadians. Now the FDA has taken up the baton to justify the support of a pharmaceutical monopoly price structure, and the massive giveaway of American tax dollars to drug companies.

And it still doesn't wash. A revolt is brewing over this massive unfunded mandate, and it's not going to get smaller. There is no good reason for Americans to be charged more than others for these drugs. If passing the development costs on to consumers in other countries is a problem, it's a problem for those countries. And there is absolutely NO good reason to ban states and cities from negotiating their own drug prices, rather than getting stuck with a full-price mandate from the federal government.

But hey, you already knew the drug companies really liked the Medicare Bill for good reasons, didn't you?

December 18, 2003

Not those Evil Drug Companies Again!

BLAME THE TORT LAWYERS!!! They're driving us out of the vaccine business with frivolous lawsuits!

It's become the standard response of the pharmaceutical industry to complaints about the shortage of flu vaccine this year. You hear it spouted by drug reps, politicians, even by doctors. And it's a bare-faced lie.

The argument is that there aren't enough doses of flu vaccine because lawsuits have made it unpofitable for pharmaceutical companies to manufacture enough vaccine. That since the federal government is the biggest single buyer of flu vaccine, federal price controls have finished the job by making it unprofitable to produce enough to make a profit. That despite the federal Vaccine Injury Compensation Program (VICP) designed to prevent it, the tort lawyers are digging through loopholes to bleed drug companies dry suing them over vaccines.

The truth is that the amount of flu vaccine produced in any given year is determined months ahead of the flu season, is based solely on projected demand, and that ALL flu-vaccine related suits ARE handled by the VICP, not the regular courts. After several years of mild flu seasons, demand had dropped off, and the drug companies accordingly manufactured less vaccine in response to the anticipated weak demand. When the quantities to be manufactured were determined, months ago, the Fujian flu strain now sweeping the country and boosting demand for vaccinations was only beginning to be noticed, and was not included in the vaccine. So less vaccine was manufactured than in the past, and there's simply no way to switch gears and produce a new vaccine (or even more of the same vaccine) overnight. It takes months.

And the other truth is that the vaccine cases now being pursued by tort attorneys outside the VICP aren't over the flu vaccine, but over mercury-containing pediatric vaccines suspected of causing the explosion in autism cases in the last two decades. The drug companies knew for years that mercury, though useful as a preservative, can produce profound neural problems in fetuses, newborns, and infants, yet they continued to sell and promote these mercury-containing vaccines even as the number of required infant vaccinations expanded, raising the doses of mercury received by infants to many times the "safe" amount for infant exposure.

Autism is a neural-developmental disorder with symptoms nearly identical to mercury poisoning. As infant mercury exposure through vaccines rose over the last two decades due to the increase in required vaccinations, so rose autism levels. While no direct mechanism has yet been established, the epidimiological evidence of a connection between mercury and autism is suggestive. (For reference, while thalidomide was indentified as causing birth defects in the early 1960's, the actual mechanism by which it did so was not found until the 1980's.)

The law says that vaccination suits must be brought through the VICP. But the VICP is designed to compensate acute (quickly appearing) adverse reactions to vaccines, not chronic late-appearing injuries like autism that may not be diagnosed for years after the exposure. As evidence of an autism/mercury connection began appearing the parents of autistic children began asking questions, and were referred to VICP, where they quickly discovered that they not only couldn't sue through the regular courts, they were barred from seeking compensation from VICP because of extremely strict time limits for filing claims. In short, if you think your child became autistic due to mercury in pediatric vaccines, it doesn't matter if you're right or wrong. You're simply out of luck, and barred from making any claims. UNLESS, as some attorneys are attempting, you can somehow file suit for intentional negligence in leaving doses of a known brain-crippling poison in infant vaccines, when the evidence that it was dangerous was there all along.

That is what the shouting was about on those clauses buried in the Homeland Security Act in the dead of night--clauses that released drug companies for ALL liability related to pediatric vaccinations, and also left the government compensation program immune from claims for same through those time limitations. The scientific verdict is still out on the mercury/autism connection, and it may be many years before medical science can say for certain if there's a solid link, and what that link is. In the meantime, tens of thousands of autistic children require massive amounts of treatment for a chance at a real life, and their families go bankrupt paying for it, and both the drug companies and the federal government fight like wolverines to immunize themselves from any liability regardless of what that truth may turn out to be. There is already considerable evidence that both the CDC and the drug companies have altered and distorted research that showed a plausible connection, and the paper shredders may well be in overdrive in many corporate headquarters.

A shortage of flu vaccine related to increased demand and panic buying provides an opportunity for the drug companies to muddy the waters on this related issue of autism/mercury suits, and they did not become the largest, most powerful corporations in the world by passing up opportunities. A panic related to any the shortage of ANY vaccine provides an opportunity to immunize themselves a bit more from their own past actions, and they're not going to let that slip away.

None of these inconvenient realities will stop the drug companies and their minions from blaming it all on the lawyers. And none of the screaming and shouting and finger-pointing will provide any relief for chronic victims of vaccine reactions. Only a comprehensive reform of the VICP to address future chronic injuries and "grandfather" existing chronic injuries into the program could do that, but that reform continues to be buried in committee, fought at every turn by both the drug companies and the administration, neither of whom want to pick up the tab, which could easily run to many billions of dollars. With tens of thousands of autistic children (and their families) suffering, this is one issue that won't go away until the truth is finally known. But it's hard to seek the truth when the full resources of the world's largest corporations and the world's wealthiest, most powerful government seem determined to bury it.

December 07, 2003

My last Medicare Drug Bill rant...maybe.

I can hear what you're thinking already...oh, no, another rant about the Medicare Drug bill! Well, yes. More precisely, a rant about a little clause therein that no one bothered to mention (or want noticed) before President Bush signs it Monday Dec. 7, and the bill becomes law.

You've already heard about the billions in subsidies for drug companies, insurance companies, and big business that make up about half the spending in this $400 billion monstrosity, including the fact that it will likely cost much more than the claimed $400 billion. Indeed, that estimate has already increased to $436 billion in the last two months. You've already heard about the prohibition on re-importing drugs into the U.S. from Canada, something that will boost prices for all drug consumers, not just the seniors who will get benefits under the new plan, and pour billions of dollars more into the pockets of the pharmaceutical industry. You may have even noticed that there's something not exactly just about all the taxes on working families required to pay for Medicare, many of whom can not afford any health insurance at all, an amount estimated to rise to as much as $4,000/yr per household under this massive unfunded behemoth.

But what seniors, the purported winners in this typically Rube Goldberg monstrosity of a pork barrel, have not yet noticed is that the new legislation that is supposed to ease their problems with high drug prices may do the exact opposite, locking them out of any alternatives. You see, not only does the bill provide a benefit with a big hole in the coverage, a hole that will grow with inflation indexing, it also prohibits seniors from buying any outside drug coverage at all to fill those gaps in the new benefit.

As reported today in the New York Times, the New Medicare Bill Bars Extra Insurance for Drugs. If you're already covered by an employer retiree policy, those expenditures don't count towards the $3600/yr deductible in the new plan. And if the drugs you're using are not part of the Medicare formulary of approved drugs, your spending on those drugs won't count towards that deductible either. So no matter what, in the complicated rules of the new plan, of the first $5,100 in annual drug expenses the patient is responsible for $3,600, period, an amount which can't be reduced by using outside coverage of any sort, and which must be spent on "approved" drugs before Medicare starts picking up 95% of the tab. So get used to generics at full "manufacturer's suggested retal price," Grandma, and don't hold your breath waiting on formulary approval of those cutting-edge drugs that the drug companies claim they must have oodles of cash to develop.

To make things even "better," low-income seniors eligible for both Medicaid and Medicare would have to obtain their drugs through Medicare, which has a more restrictive formulary offering fewer approved drugs. States will be generally prohibited from supplementing Medicare drug coverage with Medicaid drug coverage. And states will not get the discounts and rebates they now receive from manufacturers under Medicaid. So costs for state Medicaid programs will rise as well, something you won't find in the glowing reports from Congress on what a wonderful bill this is, or in the estimated cost of same.