Hi Bruce. The "vaccines" issue does not lend itself to easy answers. The balance between public health advantages of easing restrictions to get new drugs on the market and the public health advantages of preventing bad drugs from hitting the market pull in different directions. On each side of the issue there are white hats. The real question is whether we have found a good compromise under our current system.
Whenever a drug turns out to have resulted in deaths and injuries because it was not properly tested or manufactured, there will be those who attack the process and others who file lawsuits for compensation. That tends to create a more cautious environment that might have prevented the damage.
On the other hand, whenever circumstances reveal an unmet medical need that could have been met by a more expedited or less burdened approval or manufacturing environment, there will be those who will attack the safeguards and lawsuits as unjustly delaying and preventing the development and manufacture of drugs that promote the public health.
The flu shot shortage is a good one to use as an example. There is currently a "live attenuated virus" on the market as a flu mist. The "mist" replaces the shot but there are questions concering it's safety in the very young and the very old and therefor it is only approved for others. It is more quickly and easily manufactured but has some critics who say that it is too dangerous to use a "live" virus to immunize because it could lead to a more dangerous flu epidemic and who say that its effects on the old and the young have not been cleary explored. Who knows?
I think every instance must be viewed separately. In some cases the "cure" is so vital and the disease is so fatal that we must relax our rules for approval and possibly give some increased protection from lawsuits or allow valid waivers of liability. On the other hand, there is a long history in this country of doctors, drug manufacturers and other producers who have, and will, put profits ahead of the health and even the lives of their consumers. Regulation can rein in some of those abuses but regulation is usually an inefficient, slow and inadequate method of control. Lawsuits have historically served the dual purposes of creating justice for the injured and creating disincentives for manufacturers who might otherwise create substantial future harm.
The common perception today is that lawsuits are doing more good than harm. Most of the statistics cited to support the "runaway tort system" are, however, deceptive and sometimes outright lies. The perception is, however, well embedded in this nation's "common wisdom" since huge isurance interests, corporate interests and political interests have spent literally billions to create that impression. It is hardly ever questioned today and every bad, or made to appear bad, instance of a silly result at jury trial, settlement or judicial decision is exaggerated and then publicized by the insurance industrie's paid public relations people. The end result is that more people become convinced that the system is out of control, that the cause is runaway lawsuits and that expensive insurance is necessary for them and not the fault of the insurance industry.
In reality the truth lies somewhere in the middle. I wouldn't mind an exception to product liability rules which allow a drug manufacturer to escape liability for a "defective" drug by proving that it acted in good faith and that it met a standard of behavior that should be accepted as in the best interests of the health of our society. I don't think that such an exception exists. The language would have to be carefully drafted but I think that strict liability for a defective product in the drug industry goes too far and serves as a drag on the public health needs of this country. |
