Only Drugs That are Safe Should be put on the Market
The JereBeasley Report
January 2008 - Page 17

Drug developers are just beginning to come to grips with recent FDA oversight reforms and how they will affect drug safety. But, it appears that industry and consumer advocates are not together on how well the overhaul will be able to prevent future drug safety scandals. In fact, there is sharp disagreement. Signed by President George Bush in September, the measures give the Food and Drug Administration more authority over and responsibility for the safety of prescription drugs after they hit the market. Although follow-up historically fell under the agency's purview, as a practical matter the FDA focused on monitoring drug development and reviewing treatments for approval. But safety scares in recent years, such as the Vioxx saga, sparked closer scrutiny of both drug makers and the FDA, along with big changes.

Despite a development process before FDA approval, which at best has proved to be seriously flawed, a drug's side effects can go unnoticed or be deemed insignificant in small clinical populations. But once a drug hits the general market and is consumer by millions of persons, fatal risks become apparent. The FDA - simply put - is too dependent on the drug industry and that became most evident in recent years.

Drug makers and the FDA have been criticized for acting too slowly to add warnings to drug labels or recall medicines in the wake of serious safety findings. Calls for reform go back to diet pill Fen-Phen's removal from the market in 1997, but intensified after Merck & Co. recalled Vioxx because the drug's use doubled patients' heart-attack risk. When Merck agreed to pay $4.85 billion to settle Vioxx lawsuits, that told the story of how ineffective the FDA has been. British drug maker Glaxo-SmithKline is adding safety warnings to its diabetes drug Avandia because it raises cardiac risks.

The bill calls for a broader range of safety-tracking resources, allowing drug makers and regulators to cull information from hospitals, physician groups, and health insurers as well as the Centers for Disease Control. It projects the creation of a data pool of 25 million patients by 2010 and 100 million patients by 2012 for drugs on the market. While that sounds great, the logistics are still under development. How well this will work in the real world is subject to debate.

I believe it will take more than a database to effect fundamental change in drug safety. As long as the FDA is weak and ineffective, I don't see how a data ase is going to greatly improve the drug safety. Dr. Sydney Wolfe, director of the health research group at consumer and public advocacy organization Public Citizen, observed: "It isn't just a matter of funding; it's a matter of decision making. Ultimately, something structurally has to be done." Until such time as the FDA is made capable of making decisions that are not either dictated or influenced by the drug industry, the newly passed reforms will not get the job done.

Protect consumers' right to sue drugmaker
Legal action is a shield against lax regulators. Read more...

Many Unfavorable Drug Studies Aren’t Published
Nearly a third of antidepressant drug studies are never published in the medical literature, and nearly all of those happen to show that the drug being tests failed to work. Read more...

Only Drugs That are Safe Should be put on the Market
Drug developers are just beginning to come to grips with recent FDA oversight reforms and how they will affect drug safety. But, it appears that industry and consumer advocates are not together on how well the overhaul will be able to prevent future drug safety scandals. Read more...

Updates to the Biotech/Specialty Injectable Drug List – Effective July 1st
Updates to the Biotech/Specialty Injectables List for members enrolled in Flex Copay, Flex Deductible, and PPO HSA-Qualified High Deductible Health Plans went into effect July 1, 2007.Read more...

Diabetes Drugs to Get Stronger Heart-Failure Warning (Update4)
GlaxoSmithKline Plc's Avandia and Takeda Pharmaceutical Co.'s Actos, the world's best-selling diabetes pills, will carry U.S. regulators' strictest warning on the risk of heart failure. Read more...

"I would argue that the FDA ... is incapable of protecting America against another Vioxx."
-- David Graham, FDA scientist

FORSAMAX WILL MOST LIKELY BE MERCK'S NEXT BIG PROBLEM
Fosamax, which is another Merck drug. Lawsuits are being filed nationwide by people who have suffered osteonecrosis of the jaw as a s result of taking this drug. As you know, millions of women have taken Fosamax as a preventions for osteoporosis. The drug is an even larger seller than Vioxx, with 2005 sales totaling $3.5 billion. There is no know cure for the disease, and it is said to be extremely painful. The tremendous number of people on the drug and the devastating nature of the injuries make this a potentially catastrophic and widespread problem. Jerry Taylor and Chad Cook, who practice in the Mass Torts Section of our firm, are presently investigating numerous Fosamax cases on behalf of individuals across the country. We expect to file a significant number of theses cases in the next few weeks.

Source: The Jere Beasley Report (July 2006) - Beasley Allen, Crow, Methvin, Portis & Miles, P.C. Attorneys at Law